MAUDE Adverse Event Report: ETHICON INC. ETHICON MESH UNKNOWN; MESH, SURGICAL, POLYMERIC

Catalog Number ETHMESHUNK

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

Patient Problems Pain (1994); Hernia (2240); Not Applicable (3189)

Event Date 12/01/2002

Event Type  Injury  

Manufacturer Narrative

(b)(4).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.How are you currently feeling? if in your possession, may we have a copy of your operative report? does ethicon have your permission to contact your surgeon, in the event ethicon would like to contact your surgeon for more clinical information to be used for a product quality complaint investigation?.

Event Description

It was reported that a patient underwent a hernia repair procedure in (b)(6) 2001 and the unknown mesh was implanted.It was reported that about a year after the procedure, the patient started experiencing pain and a bulge in the left lower quadrant.It was reported that the patient had a re-operation in 2009 and the mesh was removed.Within the past two years, the patient has started experiencing bulging at the hernia site.No additional information was provided.

Manufacturer Narrative

Product complaint # (b)(4).Concomitant product was included to appropriate field.

• Brand Name: ETHICON MESH UNKNOWN
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 8692733
• MDR Text Key: 147776125
• Report Number: 2210968-2019-82677
• Device Sequence Number: 1
• Product Code: FTM
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup
• Report Date: 05/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: ETHMESHUNK
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/15/2019
• Patient Sequence Number: 1
• Treatment: PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT
• Patient Outcome(s): Required Intervention