It was reported that the foley catheter fell out of the patient partially deflated and caused unspecified trauma.Despite multiple good faith efforts to obtain additional information, the customer contact was unable or unwilling to provide further patient, product, or incident details to the manufacturer.The sample was received in used, unpackaged condition.No issues or abnormalities were found during testing, including at the vent, tubing, or bag.The reported issue of a deflating balloon was not confirmed through evaluation of the received sample.Due to the reported incident and in an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.
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