ELYRIA, Ohio — Last month the FDA issued a warning letter to Invacare for failure to document adequately reports of complaints involving hospital beds manufactured at the company's Sanford, Fla., plant. According to the Dec. 15 letter, posted to the FDA website, one complaint alleges the control box of a bariatric bed caught fire and two patients were taken to the hospital and treated for smoke inhalation. Another references a bed that was allegedly involved in the entrapment death of a child (age 11). Failure to "promptly" correct the documentation violations could result in regulatory action including "seizure, injunction, and/or civil money penalties," the FDA letter said.
Commenting on the warning last week, Invacare President and CEO Gerald Bloch said in a statement: "Invacare wants to assure users and the general public that we rigorously test our products and stand fully behind the safety of our products. The FDA warning letter does not state that our products are unsafe nor has it impacted our production. The letter is related to documentation procedures. We take all FDA matters very seriously, and we intend to address all of the FDA's concerns."
In a letter to the company's customers, Bloch wrote: "While much has been made in the media about the complaints listed in the FDA letter, I want to assure you that our internal investigations to date show that no injuries or death were caused by a product defect. Invacare manufactures hundreds of thousands of products, and as any business can relate, we do receive complaints. We treat these complaints with the utmost importance and investigate them thoroughly. We manufacture and test our products to the highest standards in the industry ...
"Invacare has assembled a team comprised of both internal quality and regulatory associates and outside experts to address the FDA's comments with our documentation procedures. A formal response will be submitted to the FDA as is required under the letter."