MAUDE Adverse Event Report: LIFECELL STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 20 X 20, FIRM; MESH, SURGICAL

Catalog Number 2020002

Device Problem Insufficient Information (3190)

Patient Problems Hernia (2240); Post Operative Wound Infection (2446)

Event Date 12/19/2013

Event Type  Injury  

Manufacturer Narrative

Invalid product information.If additional information is received a follow up will be submitted.

Event Description

Follow up with legal on (b)(6) 2021.No updated information received strattice was confirmed usage.Reporting in an abundance of caution.On (b)(6) 2021 abbvie legal received a complaint from a legal patient representative.Documentation was submitted for two pieces of strattice used on a patient within 1 year of each other for a hernia repair.The product did not have valid lot numbers and limited information on the failure.We reported in an abundance of caution for the most current case under, 1000306051-2021-00043, but because it could not be confirmed why strattice failed in the first procedure and used again 1 years later.This mdr is for the first use of strattice in 2013.Allergan usa, inc., allergan, inc.And lifecell were served with these new strattice complaints on (b)(6) 2021.

Manufacturer Narrative

Review of the processing history records for lot s11222 is as follows: pouch integrity inspection showed no significant bulges, holes, tears, wrinkles or physical defects.The lot was aseptically processed, terminally sterilized, and met qc release criteria.There were no processing deviations or nonconformances related to the nature of this complaint.As of 07/11/22, of the 194 devices released to finished goods for lot s11222, 192 have been distributed, with 12 reported as implanted.

Event Description

Additional information was reported to abbvie on june 22, 20022 reporting the lot number associated with this complaint, lot s11222-65 was implanted on (b)(6) 2013.

• Brand Name: STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 20 X 20, FIRM
• Type of Device: MESH, SURGICAL
• Manufacturer (Section D): LIFECELL; one millennium way; branchburg NJ 08876
• Manufacturer (Section G): BRANCHBURG; one millennium way; branchburg NJ 08876
• Manufacturer Contact: christopher belle ; one millennium way; branchburg, NJ 08876 ; 9089471470
• MDR Report Key: 12175927
• MDR Text Key: 263485288
• Report Number: 1000306051-2021-00048
• Device Sequence Number: 1
• Product Code: FTM
• UDI-Device Identifier: 00818410010140
• UDI-Public: 00818410010140
• 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: Other,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 07/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/30/2015
• Device Catalogue Number: 2020002
• Device Lot Number: S11222
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/22/2022
• 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?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female