MAUDE Adverse Event Report: LIFECELL MEDIUM CURVED SHAPE FOR STRATTICE, BPS (CONTOUR2) MESH, SURGICAL

Catalog Number CON2006

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

Patient Problems Capsular Contracture (1761); No Information (3190)

Event Date 03/15/2018

Event Type  Injury  

Manufacturer Narrative

Conclusion: based on limited information, including no identification of the relevant lot number, a relationship between the event and strattice could not be determined. Due to lack of information, strattice as a contributing factor cannot be ruled out. Lifecell reports the event in an abundance of caution. Attempts to obtain additional information are being made, including identification of the lot number. Should additional information be reported, a follow up adverse event report will be submitted; otherwise this investigation is concluded.

Event Description

This report is associated with the strattice mesh placement on the left side. Please refer to mdr 1000306051-2018-00075 for the event associated with the right side. It was reported that the female patient had bilateral breast augmentation revision surgery (b)(6) 2015 with strattice. On (b)(6) 2018, the patient had another augmentation revision on the left side due to an unspecified failure of the strattice.

• Brand Name: MEDIUM CURVED SHAPE FOR STRATTICE, BPS (CONTOUR2)
• 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: 7570729
• MDR Text Key: 110127891
• Report Number: 1000306051-2018-00074
• Device Sequence Number: 1
• Product Code: FTM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082176
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 10/31/2016
• Device Catalogue Number: CON2006
• Device Lot Number: SP100193
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 06/05/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/25/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 06/05/2018 Patient Sequence Number: 1