Medline

Description of Event or Problem

It was reported that stated gel pack leaks. Stated it is not from defrosting. Stated gel pack was at room temperature and was leaking.

Additional Manufacturer Narrative

It was reported that stated gel pack leaks. Stated it is not from defrosting. Stated gel pack was at room temperature and was leaking. Does not see any damage on item but water still comes out after being in regular temperature. There were no reports of death, serious injury, medical intervention, or follow up care. It has been determined that the reported event could cause or contribute to serious injury if it were to occur again. In an abundance of caution, this is a reportable event. If additional information becomes available this report will be reopened and reevaluated. This Medical Device Report (MDR) is being submitted as part of retrospective review activities, which include review of historical data in accordance with regulations at 21 CFR Part 803. The information included in this MDR reflects the information reasonably known to the manufacturer at the time of this retrospective review and submission.