MAUDE Adverse Event Report: LIFECELL STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 10 X 10, FIRM MESH, SURGICAL

Catalog Number 1010002

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

Patient Problem Cellulitis (1768)

Event Date 03/19/2018

Event Type  Injury  

Manufacturer Narrative

Our investigation of lot sp100543 includes: manufacturing review: review of information as reported, review of the device history records and complaint history records associated with lot sp100543. Results of evaluation: no failure detected. Review of the lot processing history and the complaint history records for lot sp100543 was unremarkable. There were no processing deviations or nonconformance related to the nature of this complaint. The lot met qc criteria for release, including mechanical testing results. As of 27 mar 2018, no other complaint has been reported to lifecell against lot sp100543. As of 27 mar 2018, of the (b)(4) devices released to finished goods for lot sp100543, all (b)(4) devices were distributed with 85 devices reported to be implanted. Based on our internal review of the device processing history, the lot met qc criteria for product release. Lot sp100543 was aseptically processed, terminally sterilized within process parameters, and met qc release criteria. No deviation was encountered in association with the reported event. No other complaint has been reported to lifecell against lot sp100543.

Event Description

It was reported that due to incarcerated inguinal hernia, the female patient underwent ventral hernia repair with strattice on (b)(6) 2018. The patient presented with postoperative cellulitis. The cause of the cellulitis is unknown as the surgeon is unsure if the reaction is related to the strattice. Surgical intervention to remove the strattice mesh was scheduled but a date was not provided.

• Brand Name: STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 10 X 10, FIRM
• 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: 7432666
• MDR Text Key: 105542206
• Report Number: 1000306051-2018-00048
• Device Sequence Number: 1
• Product Code: FTM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K070560
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health

Reporter Occupation

• Type of Report: Initial
• Report Date: 04/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 05/31/2019
• Device Catalogue Number: 1010002
• Device Lot Number: SP100543
• 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: 03/19/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/30/2017
• 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: 04/16/2018 Patient Sequence Number: 1