Oct. 31, 2011 at 5:24 PM ET
Federal health regulators now have logged 11 deaths possibly tied to tainted alcohol prep products, including those made by Wisconsin firms that remain closed because of problems with bacterial contamination, a new government report finds.
Food and Drug Administration officials also counted 121 non-fatal reports of infection potentially linked to products manufactured by H&P Industries Inc. and its sister firm, the Triad Group of Hartland, Wis., according to an analysis of adverse event reports released to msnbc.com through a public records request. Overall, the agency analyzed 232 reports of problems tied to the firms between Jan. 1, 2009 and June 28, 2011.
But no clear connection between H&P Industries products and any deaths or infections can be confirmed, FDA analysts concluded, primarily because so few cases included detailed information about the type of microbes, the particular products, or both. That includes infections possibly caused by Bacillus cereus and Elizabethkingia meningoseptica, two types of bacteria found in products later recalled by H&P Industries and the Triad Group.
"We were unable to determine whether exposure to contaminated Triad products led to serious acute bacterial infections," concluded the report dated Sept. 21 and released Monday.
The deaths tied to alcohol prep products included five that specifically mentioned the Triad Group, one that cited supplier Versapro and four that didn't specify a manufacturer. Only eight reports among the 232 cited clinical specimens or recalled Triad products.
At least eight lawsuits filed in several states claim that H&P Industries and Triad products were responsible for deaths or severe illnesses. But H&P Industries representatives have repeatedly claimed that there is no conclusive evidence that shows their products caused harm.
The Wisconsin firms have been shuttered since June after a federal court order prohibiting the firms from manufacturing or distributing medical products and supplies. The firms issued massive recalls in late 2010 and earlier this year of sterile lubricating jelly, alcohol prep wipes and povidone iodine prep wipes and swabs widely used in hospitals, clinics and private homes.