FDA Cites Innovative Medical Equipment for Risk Analyses

Innovative Medical Equipment received a Form 483 for failing to conduct adequate risk analysis for its Thermazone heating and cooling device following a July 10 to July 17 FDA inspection of its Lyndhurst, Ohio facility.

The firm’s risk analysis documents didn’t capture all potential hazards, the FDA said. The company submitted a medical device report of a serious injury when a patient fell asleep with the ThermaZone device on and sustained serious burns and blisters and permanent scarring.

The firm’s risk analysis listed the hazards associated with excessive time as “safe,” but the firm had not adequately assessed and mitigated the potential risk, the agency said.