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

Catalog Number SCF10X25AGEN

Device Problems Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)

Patient Problems Wound Dehiscence (1154); Abscess (1690); Pain (1994); Fluid Discharge (2686)

Event Date 11/16/2015

Event Type  Injury  

Manufacturer Narrative

Medwatch sent to fda on 3/30/2016.The device has not been returned.Therefore, no analysis or testing has been done.These events are being reported because medical intervention was required, although device-relatedness has not been established."fluid discharge" is a physiological complication, and analysis of the device generally does not assist allergan in determining a probable cause for this event.The reporter has declined to provide allergan further information regarding event, product, or patient details.

Event Description

Company representative reported that after implant with seri surgical scaffold, the patient developed blisters, pustules with sterile fluid coming out, with "loss of implants".Treatment status is unknown.

Manufacturer Narrative

Medwatch sent to fda on 06/16/2016.The events of wound dehiscence, abscess, bleeding, pain, induration, exposure and inadequate tissue ingrowth are physiological complications, and analysis of the device generally does not assist allergan in determining a probable cause for these events.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.

Event Description

Physician reported revision to right side breast reconstruction with seri® surgical scaffold on (b)(6) 2015.Post-implantation, the patient visited the er for bleeding on or before (b)(6) 2015 which resolved.Healing continued normally until (b)(6) 2016 when the patient presented with an opening of the wound in the right breast with redness and tenderness that had begun to drain.Physician prescribed keflex, and identified induration around the wound which was diagnosed as a well contained abscess.This was opened further and completely drained.The symptoms resolved, but by (b)(6) 2016 the redness had returned.On (b)(6) 2016 the patient presented again with drainage from the wound.Physician prescribed continued antibiotics.The wound continued to drain, and by (b)(6) 2016, the patient had developed ¿a couple of boli¿ at the right inframammary crease.These were incised and drained.Physician attributed the events to a reaction to the seri® device at this time.The wound continued to drain until (b)(6) 2016 when physician decided to remove the seri® and breast implant after a ¿silver dollar sized exposure of her implant and the seri® sling¿ developed at the wound site.The symptoms resolved after this.Physician reported that the device showed no integration with the patient tissue when it was removed.

• 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: 5536859
• MDR Text Key: 41511175
• Report Number: 8020862-2016-00026
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/03/2016

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: 03/31/2018
• Device Catalogue Number: SCF10X25AGEN
• Device Lot Number: P14121201A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/03/2016
• Initial Date FDA Received: 03/30/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/16/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/30/2015
• 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: 59 YR