MAUDE Adverse Event Report: 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 Code	Hernia (2240)
Date of Event	03/22/2013
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
It was reported through a legal event that a male patient had a hernia repair surgery prior to (b)(6) 2009, during which a strattice hernia mesh was implanted.The lot and batch numbers for that mesh are unknown at this time.On (b)(6) 2009, the patient underwent a revision/removal surgery and a second strattice hernia mesh was implanted.The records indicate this is a strattice firm 20 x 20 cm mesh.The lot and batch numbers for that mesh are s10432-021.The catalog and serial numbers for that mesh are 2020002.After surgery, the patient had a second revision/removal surgery on (b)(6) 2013.No other information was provided.This record is associated with the second device implanted; date unknown; lot s10432-021.Although a lot number was reported; s10432-021 is not a valid lot number and therefore updated to unknown.Based on the information reported, the patient underwent hernia repair on (b)(6) 2009 with lot unknown.It was reported the patient underwent revision/device removal and implanted with a second device on the same day, which does not seem plausible.It was also reported the patient underwent revision/removal surgery in march 2013 but since the implant dates do not add up, the explant date is also unclear.The date of implant for the second device has been updated to no information since it is unclear when it was implanted.The date of explant for the second device has been defaulted to (b)(6) 2013 since it was reported a second removal took place.

• Brand Name: STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 20 X 20, FIRM
• Common Device Name: MESH, SURGICAL
• Manufacturer Contact: christopher belle ; 1 millennium way; branchburg, NJ 08876 ; 9089471470
• MDR Report Key: 16091238
• Report Number: 1000306051-2022-00224
• Device Sequence Number: 6640170
• 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 Explanted Year: 2013
• 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: 2020002
• 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: Male