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2-Year-Old Dead from Tainted Alcohol Wipes, FDA Knew About Problem

Bacillus cereus, fda, triad, death of 2-year-old

Bacillus cereus, the bacteria found in the Triad product thought to have killed a 2-year-old and sickened many more.

2-year-old Harrison Kothari of Houston died in December from “a rare infection blamed on contaminated alcohol wipes,” according to MSNBC.com, which “may be only the first casualty tied to allegedly shoddy sterilization practices by a Wisconsin medical products firm.” Those shoddy sterilization practices extend not only to alcohol wipes but other medical products used in hospitals and homes, and sold as generics by many popular drug and grocery stores.

Kothari was infected with Bacillus cereus – a soil dwelling bacteria typically known for causing food poisoning – the spread of which sparked the January 5th recall of tens of millions of pads and swabs manufactured by the Triad Group (whose website is conveniently “down for maintenance” currently). Since news of Kothari’s death circulated, “dozens of people have stepped forward to say they may have been sickened, too,” MSNBC reports.

Shockingly, MSNBC believes that Food and Drug Administration inspectors have known since July 2009 that Triad had problems with contamination and sterilization. FDA regulators chided Triad in inspection reports, saying, “Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not followed,” but officials never followed up by sending the warning letters “typically used to force firms to comply” to standards.

It seems that a class-action lawsuit is brewing against Triad, as MSNBC reports that “in the last week, more than 50 people have contacted lawyers representing Sandra and Shanoop Kothari, who are suing the Triad Group for gross negligence in their son’s Dec. 1, 2010 death.” Health complaints from consumers who used the tainted product run the gamut from skin infections to another claim of death.

MSNBC notes that “a Tennessee man has filed his own $30 million lawsuit against Triad, claiming he developed an infection from Bacillus cereus from the wipes and had to undergo open-heart surgery as a result.” The man, 55-year-old Donovan Joseph Postich, is now permanently disabled.

Parents, beware: “Triad’s recall covers all lots of its alcohol prep pads, wipes and swabs,” but other Triad products may be contaminated as well – and are “often sold under private labels of grocery stores such as Safeway and Kroger and drugstores such as CVS and Walgreens.”  FDA inspectors “reported that the company could not validate the processes used to ensure quality or sterility not only of alcohol prep pads and wipes, but also other products used for intimate care,” including hemorrhoid creams, infant and adult glycerin suppositories and sterile lubricating jelly.  Additionally, “inspectors reported that Triad failed to evaluate and investigate a complaint from a hospital about high rates of abnormal pap smear results tied to the sterile lubricating jelly.”  FDA documents show that “Triad had received six similar complaints between July 2009 and May 2010,” and “more than 30 women reportedly developed vaginal irritation after a doctor used the jelly during exams, with some developing problems that had to be treated with medication for up to three weeks or more.”

It’s essential to stress the fact that not only did Triad fail to act for over a year on any complaints about its products despite knowing clearly that they were responsible for the illnesses of several people, but that the Food and Drug Administration did nothing to force Triad into action despite having recorded numerous violations on the part of the company. MSNBC acknowledges that “According to FDA protocols, Triad could have received warning letters demanding corrections of violations. If the problems weren’t fixed, the FDA could seize potentially tainted product, issue an injunction to stop business operations or force criminal prosecution that could lead to jail time or fines.” Instead, they did nothing.

An FDA investigation of Triad is “ongoing,” but no further details are available. Triad can be reached at 800.288.1288.

Source: MSNBC

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