Invacare Comments on FDA Warning

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.”