Another death has reportedly been linked to contaminated <"https://www.yourlawyer.com/practice_areas/defective_medical_devices">Triad alcohol wipes. These are the same recalled Triad alcohol wipes that had already made headlines over eight deaths, including that of toddler Harrison Kothari. Federal health investigators are now looking into the death of a 66-year-old man potentially linked to the recalled wipes, said MSNBC.
In addition to the eight deaths, 11 infections and about 250 other “problems” have also been connected to Triad Group and H&P Industries Inc. of Hartland, Wisconsin, said MSNBC, citing U.S. Food and Drug Administration (FDA) records. The latest victim developed a bacterial infection following treatment for skin cancer and diabetes, added MSNBC. The death is the second fatality reported to the FDA that mentions a Bacillus cereus infection in a patient treated with Triad’s alcohol prep pads.
Last month, we reported that, following raids; seizures; at least six lawsuits; complaints of serious illnesses; failed inspections; a number of massive recalls for tainted alcohol wipes, swabs and other medical products; and, worst of all, the death of Harrison Kothari, H&P Industries Inc. and the Triad Group now say that a permanent injunction filed by the FDA is an important step toward building their medical products business.
The firms have been accused of manufacturing and distributing alcohol products that were allegedly tainted with deadly bacteria and which have led to serious reactions in already compromised patients. The dangerous bacteria linked to the products—Bacillus cereus and Elizabethkingia meningoseptica—can lead to rare and deadly infections.
In the most recently reported case, the man was undergoing outpatient radiation treatment for squamous cell skin cancer and was also using an in-home testing product to monitor his diabetes, when he developed the deadly blood infection, according to the FDA’s Office of Surveillance and Epidemiology report, said MSNBC.
The fatality reports, said Shelly Burgess, FDA spokeswoman, are difficult to investigate because of a lack of information, said MSNBC. H&P and Triad argue that there is no direct link to their products and any death or illness, despite that the FDA received 11 reports of nonfatal infections linked to alcohol prep wipes manufactured by Triad, which include 8 linked to alcohol prep products, and 5 citing the bacteria Bacillus cereus, said MSNBC.
MSNBC noted that its ongoing investigation revealed that the agency was aware of contamination and sterilization problems going back to 2009 and involving the alcohol prep pads and other products, noting that it remains unknown how long the FDA was aware of Bacillus cereus problems because the agency “heavily redacts inspection documents.” Regardless, said MSNBC, some redactions challenged by the Milwaukee Journal Sentinel revealed that the FDA documented the pathogen in “a multi-week inspection that” initiated in last November. FDA officials finally admitted to senators Michael Bennet (Democrat-Colorado) and Lamar Alexander (Republican-Tennessee) that it should have taken “stronger action sooner,” wrote MSNBC previously.
When the FDA completed an inspection of the facility in March, multiple violations of cGMP requirements, including continuing problems with the air handling system, failure to adequately investigate drug products that did not meet specifications affecting the majority of the products manufactured at the facility, and failure to take the proper measures to ensure the quality of incoming components were revealed. The FDA previously asked H&P to stop manufacturing and distributing; it did not comply. H&P finally shut down operations shortly after the U.S. Marshalls descended on the plant. The firms described the shutdown as “voluntary.”
