MILWAUKEE -- Federal regulators have received reports of three more deaths possibly connected to contaminated alcohol wipes made and sold by a Wisconsin company, according a newly released report from the U.S. Food and Drug Administration.
That brings to 11 the number of deaths that were reported to the agency as possibly resulting from wipes and other products manufactured and sold by Hartland, Wis.,-based H&P Industries and its sister company, Triad Group.
The company has been shut down since earlier this year when U.S. marshals raided the plant and seized products suspected of being contaminated with the bacterium Bacillus cereus. The common bacterium can be deadly if it gets into the blood or spinal canal.
FDA investigators examined 232 reports received by the agency's early warning system suspected of being connected to Triad products.
FDA investigators were unable to conclude exposure to contaminated Triad products led to the illnesses or deaths because of lack of evidence, according to the Sept. 28 FDA report, released Monday to the Milwaukee Journal Sentinel through an open-records request.
The report says there is "suggestive evidence" of a connection between exposure to the contaminated products and the onset of infections, but "there were no confirmed cases to clearly establish that the Triad products served as the primary source for contamination leading to the clinical infections," according to the report, which echoes a statement the agency released to the newspaper last month.
Questions remain about how deeply FDA investigated the so-called adverse events reports regarding Triad products, including the deaths. The agency did not contact the family of a 2-year-old Houston boy who died from the same bacterium found on the Triad wipes, an attorney representing the family said last month.
A Journal Sentinel investigation found that the agency had over a decade identified problems at the Hartland plant, but not taken formal action against the company.
FDA officials were not immediately available for comment on the new report.
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