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Bacillus Cereus Linked To Triad Recall Leads To Lawsuits

Posted On February 27th, 2011 By CSSFIRM.COM

A recent death of a two year old has been linked to contaminated alcohol wipes from a plant run by the Triad Group of Hartland in Wisconsin.  Since this reported death, dozens of people have come forward saying that they may have been sickened for the same reason, according to MSNBC.com.

triad-prep-pads

This death may be the first casualty linked to contaminated Triad Group alcohol wipes.  Msnbc.com obtained government documents showing that the Food and Drug Administration inspectors were aware of problems with contamination and sterilization at a plant run by the Triad Group of Hartland as early as July 2009!  There is no record that FDA sent any type of warning letters to this company that they usually send to force firms to comply.  FDA officials only said, “Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not followed.”

The parents of the two year old who died are now suing the Triad Group for gross negligence in their son’s death on December 1, 2010.

Serious complications can result from contaminated alcohol wipes including skin infections and even death.  An agency spokesman said that about 100 reports of problems with alcohol prep pads have been logged by FDA since the January 5th recall of Triad products because of potential contamination.

There is another lawsuit against Triad filed by a Tennessee man who is claiming he developed an infection from Bacillus cereus from the alcohol wipes and he had to undergo open heart surgery as a direct result.

Msnbc.com tried contacting Triad officials by phone and e-mail but did not receive a response.  Documentation from FDA shows they had concerns with Triad between July 15 to July 17, 2009 and between April 19 and May 18, 2010.  FDA inspectors wanted the company to validate the process used to ensure quality or sterility of all their products used for intimate care including alcohol prep pads and wipes.  Triad never validated the process.  Inspectors mentioned that Triad’s process may not be adequate.  Also in the inspection report, FDA said that there was evidence of worn and broken manufacturing equipment and misidentified batches of hemorrhoid cream.  Interestingly, FDA inspectors found a batch of lubricating jelly that failed viscosity tests on January 28, 2010 but was released with specific consent of David Haertle, the president of Triad.  Apparently, a week after release, the authority to release was revised and the cases of jelly were scrapped.  Some of the cases were already distributed and no action was taken on those cases.

According to msnbc.com, a search of FDA’s online warning letters database revealed no warning letters issued to the company in 2009, 2010, or 2011.  The above mentioned inspection was first completed 16 months before two year old Harrison Kothari developed meningitis caused by Bacillus cereus bacteria and then died as a result.

FDA finally launched an official investigation last month into problems with Triad products.

A recent death of a two year old has been linked to contaminated alcohol wipes from a plant run by the Triad Group of Hartland in Wisconsin.  Since this reported death, dozens of people have come forward saying that they may have been sickened for the same reason, according to MSNBC.com.

This death may be the first casualty linked to contaminated Triad Group alcohol wipes.  Msnbc.com obtained government documents showing that the Food and Drug Administration inspectors were aware of problems with contamination and sterilization at a plant run by the Triad Group of Hartland as early as July 2009!  There is no record that FDA sent any type of warning letters to this company that they usually send to force firms to comply.  FDA officials only said, “Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not followed.”

The parents of the two year old who died are now suing the Triad Group for gross negligence in their son’s death on December 1, 2010.

Serious complications can result from contaminated alcohol wipes including skin infections and even death.  An agency spokesman said that about 100 reports of problems with alcohol prep pads have been logged by FDA since the January 5th recall of Triad products because of potential contamination.

There is another lawsuit against Triad filed by a Tennessee man who is claiming he developed an infection from Bacillus cereus from the alcohol wipes and he had to undergo open heart surgery as a direct result.

Msnbc.com tried contacting Triad officials by phone and e-mail but did not receive a response.  Documentation from FDA shows they had concerns with Triad between July 15 to July 17, 2009 and between April 19 and May 18, 2010.  FDA inspectors wanted the company to validate the process used to ensure quality or sterility of all their products used for intimate care including alcohol prep pads and wipes.  Triad never validated the process.  Inspectors mentioned that Triad’s process may not be adequate.  Also in the inspection report, FDA said that there was evidence of worn and broken manufacturing equipment and misidentified batches of hemorrhoid cream.  Interestingly, FDA inspectors found a batch of lubricating jelly that failed viscosity tests on January 28, 2010 but was released with specific consent of David Haertle, the president of Triad.  Apparently, a week after release, the authority to release was revised and the cases of jelly were scrapped.  Some of the cases were already distributed and no action was taken on those cases.

According to msnbc.com, a search of FDA’s online warning letters database revealed no warning letters issued to the company in 2009, 2010, or 2011.  The above mentioned inspection was first completed 16 months before two year old Harrison Kothari developed meningitis caused by Bacillus cereus bacteria and then died as a result.

FDA finally launched an official investigation last month into problems with Triad products. The results of this investigation are still ongoing with more details to be released in the days ahead.

Patients are supposed to be able to count on pads, wipes and swabs being sterile. They are not supposed to be concerned that these products might be contaminated. The recall described above reveals that problems associated with unsanitary and contaminated pads, wipes and swabs can potentially cause severe health issues and even death. Those negatively affected by the recalled products should investigate whether their health issues were caused by the recalled swabs and explore available remedies. Childers, Schlueter & Smith, LLC is currently investigating and reviewing Triad Recall injuries and Bacillus cereus infections nationwide. If you have questions about your use of these products or would like someone to review your potential claim please let us know.

 

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