MAUDE Adverse Event Report: ALLERGAN UNK SERI SURGICAL SCAFFOLD

Catalog Number UNK SERI SURGICAL SCAFFOLD

Device Problems Material Disintegration (1177); Patient-Device Incompatibility (2682)

Patient Problems Erythema (1840); Necrosis (1971)

Event Date 11/05/2013

Event Type  Injury  

Event Description

Company rep reported seri was implanted during reconstructive surgery with a concomitant unk breast implant, following which one week after implantation, "the flap overlying the seri became increasingly red with vascular dilatation".Initial symptoms were treated with antibiotics, however "at 8 weeks, the inferior flap thinned to the point of full thickness erosion - exposing the underlying seri.The wound closure remained intact - the breakdown was in the center of the flap".During explant surgery of seri and breast implant, "seri was found to be fully nonadherent to the flap except where suture had been placed.There was no collection/purulent fluid or evidence of infection" or fever.Physician cannot confirm the events as being device related and questions whether they are related to either the user of betadine pre-implantation or the result of "a mechanical erosion related to a thin irradiated flap -as the skin breakdown did not occur at the wound closure but in the center of the inferior flap".Seri was explanted and replaced.

Manufacturer Narrative

Further info from the reporter regarding the event and product details has been requested.No add'l info is available at this time.The physician discarded the device when it was explanted and it is no longer available for return.Therefore, allergan will not receive it and no analysis or testing will be done.The events of necrosis, exposure, erythema, and non adherence are surgical/physiological complications and analysis of the device generally does not assist allergan is determining a probable cause for these events.Device labeling addresses the reported event of exposure (impending extrusion) as follows: 'adverse reactions are those typically associated with surgically implantable materials, including infection, inflammation, adhesion formation, fistula formation, and extrusion".

• Brand Name: UNK SERI SURGICAL SCAFFOLD
• Manufacturer (Section D): ALLERGAN; medford MA
• Manufacturer (Section G): MEDFORD; 200 boston avenue; medford MA 02155
• Manufacturer Contact: karen herrera ; 71 s. los carneros rd; goleta, CA 93117 ; 8059615405
• MDR Report Key: 3677310
• MDR Text Key: 4256689
• Report Number: 3008374097-2014-00013
• 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: Health Professional,Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 02/06/2014

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 Catalogue Number: UNK SERI SURGICAL SCAFFOLD
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/06/2014
• Initial Date FDA Received: 03/07/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: IMPLANTED:; IMPLANTED WITH CONCOMITANT UNK BREAST IMPLANT; EXPLANTED:
• Patient Outcome(s): Required Intervention
• Patient Age: 34 YR