Today.com health writer JoNel Aleccia is reporting that officials at the Food and Drug Administration (FDA) did not consider the contaminated Triad alcohol prep pads to be a public health hazard until a hospital reported the infection that eventually killed a 2-year-old in Houston.
Aleccia writes, "Only then did the Food and Drug Administration act aggressively regarding the Triad Group of Hartland, Wis., whose tainted alcohol wipes and sterile lubricating jelly have been blamed for infections, serious complications and the death of a 2-year-old boy in Houston .
Aleccia reports Michael Rogers, the FDA's acting director of the Office of Regional Operations, as saying, "It was reported to our agency on Saturday and we were in that facility on Monday," but adds, "That might not have been soon enough, however, to stave off problems that may now extend to a growing number of personal care items including mouthwash, acne pads and children's cold medicine and may have left millions of potentially tainted products still in use."
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A lawsuit filed several weeks ago in federal court claims that a contaminated alcohol prep pad manufactured by Triad Group, Inc. caused the sudden death of a 2-year-old boy. The lawsuit claims Bacillus cereus bacteria from a contaminated alcohol prep pad caused a deadly meningitis infection.
"This little boy had undergone a relatively simple procedure for a benign cyst," says attorney Jim Perdue, Jr. in the lawsuit. "He was recovering well until he contracted a Bacillus cereus infection, which is not normally a hospital-acquired infection. Hospital staff had no idea how the bacteria got into the boy's spinal fluid."
On Jan. 3, 2011, a month after the boy's death, Triad Group announced a nationwide recall of all lots of its alcohol pads and swabs due to concerns of Bacillus cereus contamination.
"The missing piece of the puzzle came when the FDA announced the recall for the Triad alcohol pads and swabs for the exact bacteria contamination that killed my son," says his mother, Sandra Kothari. "These alcohol wipes are used every day in hospitals, clinics and homes. People think they're safe."
The Food and Drug Administration's website says "use of contaminated Triad Alcohol Group Prep Pads, Alcohol Swabs or Alcohol Swabsticks could lead to life-threatening infections, especially in at-risk populations, including immune suppressed and surgical patients." Triad Group has sold millions of these alcohol prep products in the U.S., Canada and Europe.
Triad Group Alcohol Prep products are used to disinfect an area prior to an injection. They were distributed to hospitals, retail pharmacies, and were included in a number of prepackaged injection kits. The affected products were marketed under the "Triad Group" label and many other private labels, including: Cardinal Health, PSS Select, Walgreens, CVS, Equate, Kroger, Life Brand, NovaPlus, Publix, Rite Aid, Rexall and Safeway.
Jim Perdue, Jr. and Donald Kidd are board certified in personal injury trial law by the Texas Board of Legal Specialization. Perdue & Kidd, L.L.P. has a national law practice based in Houston, Texas.