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	06/25/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal investigation into strattice lot sp100628 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.As of 31/aug/2021, of the 146 devices released to finished goods,139 have been distributed with 114 devices reported as implanted.
Event or Problem Description
It was reported through a legal summons that a (b)(6) female underwent an incisional hernia repair in tulsa, ok on (b)(6) 2018 and was implanted with strattice lot sp1000628-153.The patient returned to the hospital on (b)(6) 2018, was diagnosed with a severe infection, at which time she underwent paracentesis twice and underwent surgical drainage and wound vac placement.Wound cultures taken at the time of this admission tested positive for mrsa postural an stretococcus.On (b)(6) 2018 the patient was diagnosed with multiple abdominal wall abscesses due to a non-healing abdominal wound.The patient then underwent drainage of abdominal wall abscesses related to her ongoing post-surgical infection and pain.On (b)(6) 2019, she was diagnosed with a recurrent hernia.On (b)(6) 2019 she presented to st.Louis university hospital with an infected abdominal wound which did not respond to treatment.She continue to suffer from infection until the patient died on (b)(6) 2019.

• Brand Name: STRATTICE PERFORATED 16 X 20
• Common Device Name: MESH, SURGICAL
• MDR Report Key: 12509085
• Report Number: 1000306051-2021-03058
• Device Sequence Number: 5168970
• 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: 2018
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial

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: 1620002P
• Device Lot Number: SP100628
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/30/2021
• Initial Report FDA Received Date: 09/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 57 YR