ALLERGAN (MEDFORD) SERI SURGICAL SCAFFOLD (US); MESH, SURGICAL, ABSORBABLE, PLASTIC AND RECONSTRUCTIVE SURGERY
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Catalog Number SCF5X15AGEN |
Device Problem
Patient-Device Incompatibility (2682)
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Patient Problems
Anemia (1706); Hemorrhage/Bleeding (1888); Unspecified Infection (1930)
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Event Date 06/15/2015 |
Event Type
Injury
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Manufacturer Narrative
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Medwatch sent to fda on 3/9/2016.(b)(4) the reported events are physiological complications, and analysis of the device generally does not assist allergan in determining a probable cause for these events.Further information from the reporter regarding event, product, or patient details has been requested.No additional information is available at this time.The device remains implanted.Therefore no analysis or testing has been done.Device labeling addresses the reported events of extrusion and infection as follows: "adverse reactions are those typically associated with surgically implantable materials, including infection, inflammation, adhesion formation, fistula formation, and extrusion." these events are being reported because medical intervention was required, although device-relatedness has not been established.
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Event Description
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Patient reported placement of seri surgical scaffold under the left arm as part of a "reduction procedure".Patient experienced "bleeding and oozing", "staph infections", and "three to four small pieces that were coming out" were "removed".Patient also reported that the "wounds are not healing", and they have become "anemic".The events have not been confirmed by a physician.See mfg report #8020862-2016-00020 for the right side device.
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Event Description
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Patient reported placement of seri® surgical scaffold under the left arm as part of a "reduction procedure." patient experienced "bleeding and oozing", "staph infections", and "three to four small pieces that were coming out" were "removed." patient also reported that the "wounds are not healing", and they have become "anemic." the events have not been confirmed by a physician.See mfg report #8020862-2016-00020 for the right side device.Patient's physician confirmed the device had extruded.The device was placed in the arm to support brachioplasty for excess skin.The doctor believes the mobility of the implantation site contributed to the event.The doctor reported that the patient was non-compliant with post-surgical care, and refused to cooperate with his recommendations.The patient never had a "staph infection." the doctor's determination was that the wound healing issues were due to the patient's non-compliance with post-surgical protocols, not the device, and the "non-stop bleeding" and "oozing" were due to the extrusion.The doctor determined that the patient's report of anemia was due to a recent liposuction procedure that removed approximately 4 liters of tissue, not the device.The device remains implanted.
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Search Alerts/Recalls
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