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

Catalog Number CON3006

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

Patient Problem Capsular Contracture (1761)

Event Date 01/09/2020

Event Type  Injury  

Manufacturer Narrative

The strattice will not be returned as it was discarded.Qa investigation into lot sp200083 resulted in no remarkable findings including 414 devices distributed with no similar complaints against the lot and no processing deviations or nonconformances related to the nature of this complaint.Lot sp200083 was terminally sterilized and met all qc release criteria.

Event Description

It was reported that the patient experienced a recurrence of capsular contracture with baker grade iii.The strattice was placed on (b)(6) 2020 and removed on (b)(6) 2020.Lot sp200083 was affected and discarded after surgery.

• Brand Name: LARGE CURVED SHAPE FOR STRATTICE, BPS (CONTOUR3)
• 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 ; 9089471470
• MDR Report Key: 9781396
• MDR Text Key: 188139187
• Report Number: 1000306051-2020-00011
• Device Sequence Number: 1
• Product Code: FTM
• UDI-Device Identifier: 00818410010294
• UDI-Public: 00818410010294
• Combination Product (y/n): N
• PMA/PMN Number: K082176
• 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
• Report Date: 03/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2021
• Device Catalogue Number: CON3006
• Device Lot Number: SP200083
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/03/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/22/2019
• 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: 36 YR