MAUDE Adverse Event Report: ETHICON INC. PROLENE* POLY HERNIA MESH, SURGICAL, POLYMERIC

Catalog Number PHSL

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Fatigue (1849); Pain (1994); No Code Available (3191)

Event Type  Injury  

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 Description

It was reported by an attorney that the patient underwent a hernia repair surgery on 12/19/2013 and mesh was implanted. It was reported that the patient experienced an undisclosed adverse event. It was reported that the patient continues to experience pain, aching, ¿brain fog¿ and fatigue. No additional information was provided.

Manufacturer Narrative

Date sent to fda: 7/27/2018 additional information:.

• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer (Section G): ETHICON INC.; p.o. box 151, route 22 west; somerville 08876 0151
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 7362776
• MDR Text Key: 103218351
• Report Number: 2210968-2018-71223
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K984220
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 07/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 07/31/2018
• Device Catalogue Number: PHSL
• Device Lot Number: 26711-15
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 07/16/2018
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Date Device Manufactured: 11/18/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 03/22/2018 Patient Sequence Number: 1