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

Catalog Number 0416006

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Seroma (2069)

Event Date 12/15/2017

Event Type  Injury  

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 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
• Type of Device: MESH, SURGICAL
• Manufacturer (Section D): LIFECELL; 1 millennium way; branchburg NJ 08876
• Manufacturer (Section G): LIFECELL; 1 millennium way; branchburg NJ 08876
• Manufacturer Contact: christopher belle ; 1 millennium way; branchburg, NJ 08876 ; 9089471100
• MDR Report Key: 8549304
• MDR Text Key: 143393596
• Report Number: 1000306051-2019-00068
• Device Sequence Number: 1
• Product Code: FTM
• UDI-Device Identifier: 00818410010249
• UDI-Public: 00818410010249
• Combination Product (y/n): N
• PMA/PMN Number: K082176
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2019
• Device Catalogue Number: 0416006
• Device Lot Number: SP100528
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/04/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/09/2017
• 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: 47 YR