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.
|
It was reported that some time post port implant, the patient allegedly experienced allergic reaction, fibrin sheath and blood clot were formed due to heparin reaction.Therefore, the patient received prescribed medication.Reportedly, the device was replaced.Patient status is unknown.
|