MAUDE Adverse Event Report: ETHICON INC. PROLENE MESH 15X15CM MESH, SURGICAL, POLYMERIC

Catalog Number PMM3

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Erythema (1840); Inflammation (1932); Fluid Discharge (2686)

Event Date 12/29/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).   a manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.     to date the device has not been returned. If the device or further details are received at a later date a supplemental medwatch will be sent. Attempts are being made to obtain the following information.   to date no response has been provided. If further details are received at a later date a supplemental medwatch will be sent. The patient demographic info: bmi at the time of index procedure. What was the onset date of the current symptoms following the index surgical procedure? other relevant patient history/concomitant medications. What is physician¿s opinion as to the etiology of or contributing factors to this event? what is the patient's current status? what were the results of the mesh removal? was there any allergy testing performed? if yes, results?   if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

It was reported that a patient underwent a left indirect inguinal hernia repair procedure on (b)(6) 2020 and the mesh was implanted. It was reported that the patient suffered from erythema, inflammation and wound secretion after using the product in the surgery of repair of left indirect inguinal hernia with mesh on (b)(6) 2020. It was also reported that a surgery was given to remove the patch.

• Brand Name: PROLENE MESH 15X15CM
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• Manufacturer (Section G): ETHICON INC.-SAN LORENZO PR; 982 road 183 km 8.3; san lorenzo 00754
• Manufacturer Contact: elba bello ; p.o. box 151, route 22 west; somerville, NJ 08876 ; 9082182213
• MDR Report Key: 11248429
• MDR Text Key: 229336526
• Report Number: 2210968-2021-00781
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K962530
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 01/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Catalogue Number: PMM3
• Device Lot Number: PBR499
• 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: 02/08/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/05/2019
• 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: 01/28/2021 Patient Sequence Number: 1