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

Catalog Number	2020002
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bacterial Infection (1735); Hernia (2240); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	10/19/2015
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The complaint related graft was not returned.No additional information is available at this time.If additional information is received a follow up will be filed.
Event or Problem Description
Company representative reports hernia revision on ()(6) 2013 using strattice.On (b)(6) 2013 patient was diagnosis with a midline infection secondary to the strattice.On (b)(6) 2015, patient was hospitalized for a recurrent hernia.Lot numbers remain unknown.
Additional Manufacturer Narrative
The previous submission was made with a blank g3 field.The g3 field for the previous submission is [enter aware date].The previous submission was made within 30 days of the date received by manufacturer.A capa is opened to address the issue.
Event or Problem Description
Follow up.Company representative reports hernia revision on (b)(6) 2013 using strattice.On (b)(6) 2013 patient was diagnosis with a midline infection secondary to the strattice.On (b)(6) 2015, patient was hospitalized for a recurrent hernia.Lot numbers remain unknown.
Additional Manufacturer Narrative
Review of the processing history records for lot sp100148 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 07/08/22, of the (b)(4) devices released to finished goods for lot sp100148, (b)(4) have been distributed, with (b)(4) have been 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 (b)(4) implanted on (b)(6) 2014.

• 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: 11853083
• Report Number: 1000306051-2021-00043
• Device Sequence Number: 3847067
• 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: 2014
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,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: 07/14/2016
• Device Catalogue Number: 2020002
• Device Lot Number: SP100148
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 04/21/2021; 06/22/2022
• Initial Report FDA Received Date: 05/19/2021
• Supplement Report FDA Received Date: 07/07/2021; 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