As the lot number for the device was not provided, a manufacturing review could not be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.
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It was reported sometime post pot placement the port site allegedly became hardened, inflamed and appeared ulcerated.Reportedly, the device was removed.There was no device deficiency reported.It was further reported the patient was prescribed antibiotic medication.The patient was reported to be stable post port removal procedure.
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