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

Catalog Number	2020002
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Hernia (2240); Post Operative Wound Infection (2446)
Date of Event	12/19/2013
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Invalid product information.If additional information is received a follow up will be submitted.
Event or Problem 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.
Additional 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 or Problem 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
• Common Device Name: 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
• Report Number: 1000306051-2021-00048
• Device Sequence Number: 1622333
• Product Code: FTM
• UDI-Device Identifier: 00818410010140
• UDI-Public: 00818410010140
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K070560
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2013
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/15/2022

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: 01/30/2015
• Device Catalogue Number: 2020002
• Device Lot Number: S11222
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/14/2021
• Supplement Date Received by Manufacturer: 06/22/2022
• Initial Report FDA Received Date: 07/15/2021
• Supplement Report FDA Received Date: 07/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female