MAUDE Adverse Event Report: STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 10 X 16, FIRM; MESH, SURGICAL

Catalog Number	1016002
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hernia (2240)
Date of Event	04/13/2010
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported through a legal event that a male patient had hernia repair surgery on (b)(6) 2010.During the hernia repair surgery, the surgeon implanted a strattice; the records indicate this is a strattice firm mesh; the lot and batch numbers for that mesh are s16582-181.The catalog and serial numbers for that mesh are (b)(4).After surgery, the patient had a revision/removal surgery on april 13, 2010.During that surgery, the surgeon implanted a second strattice mesh in him.The records indicate this is a strattice firm mesh.The lot and batch numbers for that mesh are s10807-161.The catalog and serial numbers for that mesh are (b)(4).On (b)(6) 2011, the patient had a revision/removal surgery.No other information was provided.This record is associated with the device implanted on (b)(6) 2010; lot s16582-181.Although a lot number was reported, s16582-181 is not a valid lot number.
Additional Manufacturer Narrative
This legal event is being reported as serious injury due to the reported recurrence with surgical intervention.The lot associated with this event was not reported and remains unknown; therefore an internal investigation into the device history records could not be performed.No strattice devices were returned for evaluation.Based on the limited information, including no identification of the lot number, and without relevant patient factors, a relationship between the event and the strattice could not be determined.Due to the legal process, if additional information is made available during legal proceedings, a supplemental report will be submitted.

• Brand Name: STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 10 X 16, FIRM
• Common Device Name: MESH, SURGICAL
• Manufacturer Contact: christopher belle ; 1 millennium way; branchburg, NJ 08876 ; 9089471470
• MDR Report Key: 16086777
• Report Number: 1000306051-2022-00221
• Device Sequence Number: 17825902
• Product Code: FTM
• UDI-Device Identifier: 00818410010119
• UDI-Public: 00818410010119
• 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: 2010
• Device Explanted Year: 2010
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/03/2023

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 Catalogue Number: 1016002
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/19/2022
• Initial Report FDA Received Date: 01/03/2023
• 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): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NO INFORMATION REPORTED
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown