MAUDE Adverse Event Report: STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 8 X 8, FIRM; MESH, SURGICAL

Catalog Number	0808002
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hernia (2240)
Date of Event	10/19/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported through a legal event that a 60 year old female patient had hernia repair surgery on or about (b)(6) 2015.During the hernia repair surgery, the surgeon implanted a strattice mesh, lot number sp100232-182, ref number 0808002.After surgery, the patient returned to the hospital on or about (b)(6) 2021.Patient was diagnosed with recurrent ventral hernia with irreducibility and underwent a removal of foreign body from the torso and open ventral hernia repair with mesh.There was inflammation present and the omentum was adhered under the abdominal wall, and omentum and mesh were cut away and removed.The rest of the mesh was removed and patient sustained a fistula, recurrent hernia, adhesions, and infection.
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 sp100232 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 290 devices released to finished goods for lot sp100232, 275 have been reported as distribution with 161 reported as implanted.Based on our internal investigation 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 RECONSTRUCTIVE TISSUE MATRIX, 8 X 8, FIRM
• Common Device Name: MESH, SURGICAL
• Manufacturer Contact: christopher belle ; 1 millennium way; branchburg, NJ 08876 ; 9089471470
• MDR Report Key: 15462997
• Report Number: 1000306051-2022-00150
• Device Sequence Number: 6873912
• Product Code: FTM
• UDI-Device Identifier: 00818410010362
• UDI-Public: 00818410010362
• 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: 2015
• 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): 09/21/2022

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: 0808002
• Device Lot Number: SP100232
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/29/2022
• Initial Report FDA Received Date: 09/22/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 60 YR
• Patient Sex: Female