MAUDE Adverse Event Report: LIFECELL BPS STRATTICE 4 CM X 16 CM - PLIABLE; MESH, SURGICAL

Catalog Number	0416006
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Seroma (2069)
Date of Event	12/15/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned to lifecell for evaluation as it was discarded.The internal investigation into lot sp100528 included a review of the reported information, review of the device history records and review of the complaint history records.Investigation results revealed no remarkable findings with no similar complaints reported against the lot and no processing deviations or nonconformances related to the nature of this event.The lot was terminally sterilized within the process parameters and met all qc release criteria.To date, of the (b)(4) devices released to finished goods for lot sp100528, (b)(4) have been distributed.Based on our internal review with no remarkable findings, a relationship to the strattice device and this event could not be determined.Other surgical or patient factors could also contribute to this event.No further actions are required as a nonconformance could not be confirmed.
Event or Problem Description
It was reported that a patient was implanted with strattice bps (lot number: sp100528) on (b)(6) 2017.In the months following the surgery, the patient experienced fluid accumulation surrounding the breast alternating from one side to the other.The surgeon advised they believed the fluid was an ¿inflammatory response due to the tissue never integrating into the skin.¿ on (b)(6) 2019 the patient had the strattice explanted.The product has now been discarded and is not available for return.

• Brand Name: BPS STRATTICE 4 CM X 16 CM - PLIABLE
• Common Device Name: MESH, SURGICAL
• Manufacturer (Section D): LIFECELL; 1 millennium way; branchburg NJ 08876
• MDR Report Key: 8549304
• Report Number: 1000306051-2019-00068
• Device Sequence Number: 2443989
• Product Code: FTM
• UDI-Device Identifier: 00818410010249
• UDI-Public: 00818410010249
• Combination Product (Y/N): N
• Initial Reporter State: CA
• PMA/510(K) Number: K082176
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2019
• Device Catalogue Number: 0416006
• Device Lot Number: SP100528
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/04/2019
• Initial Report FDA Received Date: 04/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 47 YR