MAUDE Adverse Event Report: STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 20 X 25, FIRM; MESH, SURGICAL

Catalog Number	2025002
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hernia (2240)
Date of Event	10/05/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to ps by the legal department that a patient underwent hernia repair and implanted with strattice on (b)(6) 2017.There were other revision surgeries on (b)(6)2018 and (b)(6) 2019.No other information was reported.The lot (s) associated with this complaint remains unknown.
Additional Manufacturer Narrative
The lot associated with this event was not reported and remains unknown; therefore a review of the device history records could not be performed.No strattice devices were returned for evaluation.Based on the limited information reported, a relationship between the event and strattice could not be determined.Due to the legal process, if additional information is made available during legal proceedings, the information will be sent to product surveillance for further evaluation.To date, no additional information has been received.No further actions are required, a nonconformance was not confirmed.
Additional Manufacturer Narrative
This is a follow up #1 report to the internal investigation and conclusion.Internal investigation into strattice lot sp100443 included a review of the reported information, review of the device history records, and a review of the complaint history records with no remarkable findings, including one complaint reported against the lot and no associated deviations or non-conformances revealed during processing.The lot was aseptically processed, terminally sterilized within the process parameters, and met all qc release criteria.To date, of the (b)(4) devices released to finished goods, (b)(4) have been distributed with 126 devices reported as implanted.Due to the legal process, if additional information is made available during legal proceedings, a supplemental report will be submitted.
Event or Problem Description
This is follow-up #1 to report additional information reporting the lot number associated with this complaint.Lot sp100443-174.

• Brand Name: STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 20 X 25, FIRM
• Common Device Name: MESH, SURGICAL
• Manufacturer Contact: christopher belle ; 1 millennium way; branchburg, NJ 08876 ; 9089471470
• MDR Report Key: 14346383
• Report Number: 1000306051-2022-00086
• Device Sequence Number: 5220411
• Product Code: FTM
• UDI-Device Identifier: 00818410010157
• UDI-Public: 00818410010157
• 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: 2017
• 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): 07/22/2022

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 Catalogue Number: 2025002
• Device Lot Number: SP100443
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/14/2022
• Supplement Date Received by Manufacturer: 07/05/2022
• Initial Report FDA Received Date: 05/10/2022
• Supplement Report FDA Received Date: 07/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• 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; NO INFORMATION REPORTED
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 42 YR
• Patient Sex: Male