MAUDE Adverse Event Report: STRATTICE PERFORATED 16 X 20; MESH, SURGICAL

Catalog Number	1620002P
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hernia (2240)
Date of Event	08/11/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported through a legal event that a 62 year old male patient had hernia repair surgery on or about (b)(6) 2019.During the hernia repair surgery, the surgeon implanted a strattice perforated mesh, 1620002p and the lot number is sp200029-123.After surgery, the patient returned to the hospital on or about (b)(6) 2020 and was diagnosed with a recurrent ventral hernia.On or about (b)(6) 2020, the patient underwent a revision surgery.Omental adhesions were noted and freed, and the large recurrent hernia was repaired.On or about (b)(6) 2021, the patient presented to (b)(6) in (b)(6) and was noted to have recurrent hernias.He underwent a revision and removal surgery to repair the recurrent hernias, where adhesions were noted and a portion of the mesh was dissected out.
Additional Manufacturer Narrative
Internal investigation into strattice lot sp200029 included a review of the reported information, review of the device history records, and a review of the complaint history records.The investigation resulted in no remarkable findings, including no other complaints reported against the lot and no deviations or related non-conformances revealed during processing.The lot was terminally sterilized within the process parameters and met all qc release criteria.As of (b)(6) 2022, of the 142 devices released to finished goods for lot sp200029, (b)(4) have been distributed with 69 reported as implanted.Based on our internal review with no remarkable findings, and without relevant patient factors, a relationship between the strattice and this event 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 PERFORATED 16 X 20
• Common Device Name: MESH, SURGICAL
• Manufacturer Contact: christopher belle ; 1 millennium way; branchburg, NJ 08876 ; 9089471470
• MDR Report Key: 14990452
• Report Number: 1000306051-2022-00116
• Device Sequence Number: 1597007
• Product Code: FTM
• UDI-Device Identifier: 00818410012298
• UDI-Public: 00818410012298
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K150712
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2021
• 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): 07/12/2022

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: 07/31/2020
• Device Catalogue Number: 1620002P
• Device Lot Number: SP200029
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/17/2022
• Initial Report FDA Received Date: 07/12/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 62 YR
• Patient Sex: Male