A biopsy site identifier is a sterile, single-patient use device that is placed into soft tissue during a biopsy procedure to radiographically mark a surgical location.It is suspected that this adverse event is related to mammostar biopsy site identifiers but this could not be confirmed because no catalog number or lot identification information could be obtained.The procedure was completed, with three identifiers placed, with no reaction at that time.The patient reported a year later that all three sites developed some kind of tissue reaction "unconfirmed abscess." all three identifiers have been removed and two sites have fully resolved.The third identifier was removed three weeks ago and the recovery is ongoing.No additional information has been able to be obtained.The device was not returned for evaluation.Biocompatibility testing has been conducted and has determined that the device is non-irritating and non-sensitizing.The device history record was not reviewed because lot identification information could not be obtained.Appropriate controls are in place, however, for every lot manufactured to ensure that no discrepancies exist before release, including packaging and sterilization records.The information contained herein is being provided to fda to comply with regulations relating to medical device reporting and is based on information submitted by others that may not be factually correct.This submission does not constitute a determination or admission that a device has malfunctioned or that a device is related to a death or injury.
|