MAUDE Adverse Event Report: ALLERGAN (MEDFORD) SERI SURGICAL SCAFFOLD (US); MESH, SURGICAL, ABSORBABLE, PLASTIC AND RECONSTRUCTIVE SURGERY

Catalog Number SCF5X15AGEN

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Anemia (1706); Hemorrhage/Bleeding (1888); Unspecified Infection (1930)

Event Date 06/15/2015

Event Type  Injury  

Manufacturer Narrative

Medwatch sent to fda on 03/09/2016.(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.

Event Description

Patient reported placement of seri surgical scaffold under the right 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 mfr report #8020862-2016-00019 for the left side device.

Manufacturer Narrative

Medwatch sent to fda on 04/07/2016.

Event Description

Patient reported placement of seri surgical scaffold under the right 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 #8020862-2016-00019 for the left 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.

• Brand Name: SERI SURGICAL SCAFFOLD (US)
• Type of Device: MESH, SURGICAL, ABSORBABLE, PLASTIC AND RECONSTRUCTIVE SURGERY
• Manufacturer (Section D): ALLERGAN (MEDFORD); 200 boston avenue; medford MA 02155
• Manufacturer (Section G): ALLERGAN (MEDFORD); 200 boston avenue; medford MA 02155
• Manufacturer Contact: suzanne wojcik ; 301 w howard lane; suite 100; austin, TX 78753 ; 7372473605
• MDR Report Key: 5488607
• MDR Text Key: 39944672
• Report Number: 8020862-2016-00020
• Device Sequence Number: 1
• Product Code: OXF
• Combination Product (y/n): N
• PMA/PMN Number: K123128
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup
• Report Date: 02/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2017
• Device Catalogue Number: SCF5X15AGEN
• Device Lot Number: P14030301A
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/16/2016
• Initial Date FDA Received: 03/09/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/07/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/30/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR