MAUDE Adverse Event Report: ALLERGAN SERI SURGICAL SCAFFOLD (US)

Catalog Number SCF10X25AGEN

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Wound Dehiscence (1154); Capsular Contracture (1761); Erythema (1840); Necrosis (1971); Seroma (2069); Fluid Discharge (2686)

Event Date 03/25/2014

Event Type  Injury  

Event Description

Company representative reported revision reconstruction surgery with implantation of seri and a concomitant cohesive silicone gel device was performed on (b)(6) 2014.Patient initially presented on (b)(6) 2014 with right side erythema overlying the implanted seri, treated with oral bactrim antibiotics.Patient developed capsular contracture, baker grade unknown, with treatment consisting of singulair.During a follow up evaluation, physician diagnosed a seroma resulting in drainage of "yellow, serous fluid" and "pressure necrosis." physician also noted a "[2mm] spot on the incision that is opened," located where a previous tumor was removed.The opening was initially "loosely closed," however, the seri device was eventually fully explanted on (b)(6) 2014, and physician "closed over a drain after debriding all of the non-viable skin." physician noted "all of the skin directly overlying the seri was viable and intact, albeit extremely thin and still not very healthy.But, there was a very distinct line of demarcation exactly at the margin of the seri," the explanted device was discarded and is unavailable for return.

Manufacturer Narrative

(b)(4).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, wound dehiscence, drainage, seroma, erythema, and capsular contracture are surgical/physiological complications and analysis of the device generally does not assist allergan in determining a probable cause for these events.These events are being reported because medical intervention was required, although device-relatedness has not been established.

• Brand Name: SERI SURGICAL SCAFFOLD (US)
• Manufacturer (Section D): ALLERGAN; medford MA
• Manufacturer Contact: karen herrera ; 71 s. los carneros rd.; goleta, CA 93117 ; 8059615867
• MDR Report Key: 3848642
• MDR Text Key: 4618333
• Report Number: 3008374097-2014-00030
• Device Sequence Number: 1
• Product Code: OXF
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: Other
• Type of Report: Initial
• Report Date: 05/02/2014

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 Expiration Date: 08/31/2015
• Device Catalogue Number: SCF10X25AGEN
• Device Lot Number: P12081301
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/02/2014
• Initial Date FDA Received: 05/21/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2012
• 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: EXPLANT:; STYLE 410 COHESIVE SILICONE GEL DEVICE; IMPLANT:
• Patient Outcome(s): Required Intervention
• Patient Age: 48 YR