Documents show sterilization issues as early as 2009; dozens may have been sickened.
The death of a 2-year-old Houston boy from a rare infection blamed on contaminated alcohol wipes may be only the first casualty tied to allegedly shoddy sterilization practices by a Wisconsin medical products firm.
Since MSNBC.com reported Feb. 15 about the death of Harrison Kothari , who was infected with the same type of rare bacteria that sparked the recall of tens of millions of pads and swabs, dozens of people have stepped forward to say they may have been sickened, too. Here are excerpts from reports run by MSNBC:
At the same time, government documents obtained by msnbc.com showed that federal Food and Drug Administration inspectors knew about problems with contamination and sterilization at a plant run by the Triad Group of Hartland, Wis., as early as July 2009.
“Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not followed,” officials wrote in inspection reports. But there’s no record that the FDA sent warning letters typically used to force firms to comply.
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.
Reported injuries range from superficial skin infections to serious complications, and even one claim of another death.
Another 100 reports of problems with alcohol prep pads have been logged by the FDA since the Jan. 5 recall of Triad products because of potential contamination with the bacteria Bacillus cereus, an agency spokesman said.
Triad’s recall covers all lots of its alcohol prep pads, wipes and swabs, totaling perhaps hundreds of millions of products sold in the U.S., Canada and Europe.
H&P Industries, which does business as the Triad Group, is among the largest providers in the U.S. of generic medical products often sold under private labels of grocery stores such as Safeway and Kroger and drugstores such as CVS and Walgreens.
