MAUDE Adverse Event Report: ETHICON INC. PROLENE SFT PP MSH 20X20IN 50X50CM; MESH, SURGICAL, POLYMERIC

Catalog Number	SPM3XL
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Abdominal Pain (1685); Adhesion(s) (1695); Scarring (2061); Blood Loss (2597)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).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 hernia surgery on (b)(6) 2017 and mesh was implanted.It was reported that the patient experience adhesions and scarring.No additional information was provided.
Additional Manufacturer Narrative
(b)(4).It was reported that following the procedure the patient experienced abdominal pain and bleeding of the abdominal wound.No additional information was provided.

• Brand Name: PROLENE SFT PP MSH 20X20IN 50X50CM
• 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: 7904971
• Report Number: 2210968-2018-75847
• Device Sequence Number: 13876307
• Product Code: FTL
• UDI-Device Identifier: 10705031238824
• UDI-Public: 10705031238824
• Combination Product (Y/N): N
• PMA/510(K) Number: K962530
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/11/2018

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: 09/30/2021
• Device Catalogue Number: SPM3XL
• Device Lot Number: KLH987
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/14/2018
• Supplement Date Received by Manufacturer: 12/11/2018
• Initial Report FDA Received Date: 09/25/2018
• Supplement Report FDA Received Date: 12/26/2018
• 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: 64 YR