Invacare Corp. was warned by the U.S. Food and Drug Administration that manufacturing violations may result in fire and entrapment hazards in its electric beds. The company’s shares fell the most since June.
Invacare, based in Elyria, Ohio, failed to respond adequately to complaints about the flaws, which may be linked to patient deaths, the FDA said in a Dec. 15 letter posted today on the agency’s website.
One complaint alleged that an 11-year-old child died after becoming trapped by an Invacare bed rail. Another patient died after one of the company’s beds caught fire, according to the agency. Two other patients were taken to the hospital and treated for smoke inhalation and chest pain after the control box of an Invacare bed caught fire, the FDA said.
The company has 15 days to notify the FDA of steps it’s taking to correct violations at an Invacare site in Sanford, Florida, and to prevent further incidents. Failure to fix the flaw may result in “seizure, injunction, and/or civil money penalties,” the agency said.
“We rigorously test our products and stand fully behind the safety of our products,” President and Chief Executive Officer Gerald Blouch said in a statement today. He added that the warning letter didn’t call the products unsafe, and said production was unaffected. The company has assembled a team to assess the FDA concerns and would respond to the agency, he said.
Invacare fell $1.38, or 4.5 percent, to $29.29 at 4:15 p.m. in New York Stock Exchange composite trading, the steepest percentage decline since June 4. The stock has gained 16 percent in the past 12 months.