MAUDE Adverse Event Report: STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 30 X 30CM, FIRM; MESH, SURGICAL

Catalog Number	3030002
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hernia (2240)
Date of Event	06/23/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported through a legal event that a (b)(6) women underwent hernia repair surgery on or about (b)(6) 2015.The surgeon performed the recurrent incarcerated midline and incisional hernia repair at the medical center (b)(6).During the hernia repair surgery, the surgeon implanted a strattice mesh in the patient.The records indicate it was strattice mesh item 3030002, lot sp100244-319.After surgery, the patient returned to the hospital on or about (b)(6) 2016 for a mesh explant surgery at the medical center (b)(6).
Additional Manufacturer Narrative
This legal event is being reported as serious injury due to the reported recurrence with surgical intervention.Internal investigation into strattice lot sp100244 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 no other complaints reported against the lot and no 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 (b)(4) devices reported as implanted.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, 30 X 30CM, FIRM
• Common Device Name: MESH, SURGICAL
• Manufacturer Contact: christopher belle ; 1 millennium way; branchburg, NJ 08876 ; 9089471470
• MDR Report Key: 13588029
• Report Number: 1000306051-2022-00016
• Device Sequence Number: 12217344
• Product Code: FTM
• UDI-Device Identifier: 00818410011796
• UDI-Public: 00818410011796
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K070560
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2016
• 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): 02/23/2022

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: 3030002
• Device Lot Number: SP100244
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/04/2022
• Initial Report FDA Received Date: 02/23/2022
• 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): 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 Age: 43 YR
• Patient Sex: Female