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 Type  Injury  

Manufacturer Narrative

Based on the information reported, including no identification of the relevant lot number, a relationship between the event and strattice cannot be determined.Strattice as a contributing factor cannot be ruled out.Multiple attempts were made to gather additional information; however to date, no further information has been obtained.The device was not returned for evaluation as it was discarded and the lot number remains unknown; therefore internal investigation into the event could not be performed.If additional information is reported, a follow up adverse event report will be submitted.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 on (b)(6) 2019.In the months following surgery, the patient experienced recurrent capsular contracture on the right breast.Explant of the device occurred on (b)(6) 2019.The device was discarded and is not available for return.

• 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 ; 9089471100
• MDR Report Key: 8612667
• MDR Text Key: 145137929
• Report Number: 1000306051-2019-00071
• 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

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
• Device Operator: Health Professional
• Device Catalogue Number: CON3006
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/19/2019
• Initial Date FDA Received: 05/15/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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