MAUDE Adverse Event Report: ETHICON INC. PROLENE*SOFT POLYPROPYLENE MESH; MESH, SURGICAL, POLYMERIC

Catalog Number	SPMS
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Ischemia (1942); Hernia (2240)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
To date, the device has not been returned.If the product is returned for evaluation, any further information derived from the evaluation will be submitted in a supplemental 3500a form.In addition, a device history review has been inserted into the file.This review indicates that there was no quality concerns associated with the manufacturing process.
Event or Problem Description
It was reported by an attorney that the patient underwent a recurrent left direct inguinal hernia repair surgery on (b)(6) 2007 and mesh was implanted.Additional information was provided that the patient underwent surgery on (b)(6) 2017 for left inguinal hernia ¿with defect through the center of the mesh and small bowel resection, excising eight inches of ischemic small intestine.¿ no additional information is provided.
Additional Manufacturer Narrative
Date sent to fda: 8/8/2019.

• Common Device Name: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 7835934
• Report Number: 2210968-2018-75350
• Device Sequence Number: 13948476
• Product Code: FTL
• UDI-Device Identifier: 10705031050495
• UDI-Public: 10705031050495
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K962530
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/08/2019

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: 01/31/2008
• Device Catalogue Number: SPMS
• Device Lot Number: SDE926
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/21/2018
• Supplement Date Received by Manufacturer: 08/08/2019
• Initial Report FDA Received Date: 08/30/2018
• Supplement Report FDA Received Date: 08/08/2019
• 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