MAUDE Adverse Event Report: LIFECELL LARGE CURVED SHAPE FOR STRATTICE, BPS (CONTOUR3); MESH, SURGICAL

Catalog Number	CON3006
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Capsular Contracture (1761)
Date of Event	11/05/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has not been returned to allergan for evaluation and it is unknown at this time if the strattice was removed.Based on limited information, a relationship between the event and the strattice could not be determined.Due to lack of information, strattice as a contributing factor cannot be ruled out.Lifecell reports the event in abundance of caution.Multiple attempts to obtain additional information are being made; however to date, no further information has been obtained our internal investigation of lot sp100512 includes a review of the reported information, a review of the device history results, and a review of the complaint history records.The review processing history records for lot sp100512 was unremarkable.The lot was aseptically processed and terminally sterilized within process parameters.There were no processing deviations or nonconformance related to the nature of this complaint.There was one unrelated complaint reported to allergan against lot sp100512.As of (b)(6) 2018, of the 478 devices released to finished goods for lot sp100512, 473 have been distributed.Of the 473 distributed, 137 have been reported as implanted.Based on our internal review, lot sp100512 met qc criteria for release.Should additional information be reported, a follow up adverse event report will be submitted.
Event or Problem Description
Healthcare professional reported left side capsular contracture, baker grade "iii-iv".Device status is unknown.

• Brand Name: LARGE CURVED SHAPE FOR STRATTICE, BPS (CONTOUR3)
• Common Device Name: MESH, SURGICAL
• Manufacturer (Section D): LIFECELL; 1 millennium way; branchburg NJ 08876
• MDR Report Key: 8210114
• Report Number: 1000306051-2018-00167
• Device Sequence Number: 18898337
• Product Code: FTM
• UDI-Device Identifier: 00818410010294
• UDI-Public: 00818410010294
• 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: 2018
• 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: 02/28/2019
• Device Catalogue Number: CON3006
• Device Lot Number: SP100512
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/05/2018
• Initial Report FDA Received Date: 01/02/2019
• 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