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

Catalog Number	SPMH
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Undisclosed injuries.Undefined device problem.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.A device history review has been inserted into the file.This review indicates that there was no quality concerns associated with the manufacturing process.The manufacturer date and expiration date have been obtained.File has been updated accordingly.
Event or Problem Description
It was reported by an attorney that the patient underwent a hernia repair surgery on (b)(6) 2015 and mesh was implanted.It was reported that the patient experienced pain and had to undergo additional medical treatments.No additional information was provided.

• Common Device Name: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville 08876 0151
• MDR Report Key: 7057521
• Report Number: 2210968-2017-71248
• Device Sequence Number: 13771259
• Product Code: FTL
• UDI-Device Identifier: 10705031050464
• UDI-Public: 10705031050464
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K962530
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/06/2017

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: 07/31/2019
• Device Catalogue Number: SPMH
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2017
• Initial Date Received by Manufacturer: 11/06/2017
• Initial Report FDA Received Date: 11/24/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 62 YR