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 Cellulitis (1768); Seroma (2069)

Event Date 05/29/2020

Event Type  Injury  

Manufacturer Narrative

Based on current information, relationship of this event cannot be determined. The internal investigation into lot # sp200194 included a review of the reported information, review of the complaint history records. There are no other complaints against this lot. Device history review has been requested, and is currently ongoing. Further follow up with the reporting healthcare professional will be conducted to obtain additional patient and event information. It was reported that the device will not be returned for analysis.

Event Description

Healthcare professional reported that patient developed heavy seroma out put around the strattice, which resulted in the removal of it. "patient is doing well. ".

• 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: brent livingstone ; 1 millennium way; branchburg, NJ 08876 ; 9089471470
• MDR Report Key: 10251393
• MDR Text Key: 198319013
• Report Number: 1000306051-2020-00032
• Device Sequence Number: 1
• Product Code: FTM
• 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

• Type of Report: Initial,Followup
• Report Date: 08/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 12/31/2021
• Device Catalogue Number: CON2006
• Device Lot Number: SP200194
• 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: 06/03/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/17/2020
• 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: 07/09/2020 Patient Sequence Number: 1