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

Catalog Number	1010002
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cellulitis (1768)
Date of Event	03/19/2018
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: MESH, SURGICAL
• Manufacturer (Section D): LIFECELL; 1 millennium way; branchburg NJ 08876
• MDR Report Key: 7432666
• Report Number: 1000306051-2018-00048
• Device Sequence Number: 13781552
• Product Code: FTM
• UDI-Device Identifier: 00818410010096
• UDI-Public: 00818410010096
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K070560
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/12/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2019
• Device Catalogue Number: 1010002
• Device Lot Number: SP100543
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/19/2018
• Initial Report FDA Received Date: 04/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 51 YR