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

Catalog Number PMM3

Device Problem Material Protrusion/Extrusion (2979)

Patient Problems Necrosis (1971); Not Applicable (3189); No Code Available (3191)

Event Date 06/20/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Attempts are being made to retrieve the device.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: weight, bmi at the time of index procedure? what were current symptoms following the index surgical procedure? onset date? what are the patient comorbidities/ concomitant medications? were there any intra-operative complications? what is physician¿s opinion as to the etiology of or contributing factors to this event? what is the patient's current status? did the patient experience mesh extrusion? if so: what was the initial approach for the index surgical procedure? when was the mesh extrusion first noted by a physician? mesh extrusion site/ location, symptoms and diagnostic confirmation? describe any medical/ surgical intervention for mesh extrusion including dates and surgical findings.

Event Description

It was reported that a patient underwent a tension free bilateral inguinal hernia repair on (b)(6) 2020 and the mesh was implanted.A mesh extrusion was reported.It was also reported that the patient suffered from wound secretion on the 8th postoperative day after using the patch in the surgery.It was also reported that considering fat liquefaction, dressing change was given, but necrosis of subcutaneous tissue was found on (b)(6).It was reported that dressing change will be given for the next week, and if it doesn't help, transfer of hospital may be considered for further treatment.

Manufacturer Narrative

Product complaint # (b)(4).A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.Method codes: the following information was requested, but unavailable: what were current symptoms following the index surgical procedure? onset date? what are the patient comorbidities/concomitant medications? were there any intra-operative complications? what is physician¿s opinion as to the etiology of or contributing factors to this event what is the patient's current status? did the patient experience mesh extrusion? if so: what was the initial approach for the index surgical procedure? when was the mesh extrusion first noted by a physician? mesh extrusion site/location, symptoms and diagnostic confirmation? describe any medical/surgical intervention for mesh extrusion including dates and surgical findings.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• 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
• MDR Report Key: 10312370
• MDR Text Key: 200013625
• Report Number: 2210968-2020-05471
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• PMA/PMN Number: K962530
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/29/2020

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2023
• Device Catalogue Number: PMM3
• Device Lot Number: MHJ141
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/29/2020
• Initial Date FDA Received: 07/23/2020
• Supplement Dates Manufacturer Received: 07/30/2020
• Supplement Dates FDA Received: 07/30/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 52 YR