MAUDE Adverse Event Report: ETHICON INC. PROLENE MESH 3INX6IN; MESH, SURGICAL, POLYMERIC

Model Number PMII

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

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

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.

Event Description

It was reported by an attorney that the patient underwent removal surgery and recurrent hernia repair surgery on (b)(6) 2009 and mesh was implanted during which the surgeon noted evidence of old mesh.There was a wad of mesh at the internal ring.There was also mesh along the patient¿s inguinal canal and including external oblique.Once the mesh was removed, the vas deferens of the spermatic cord was noted.There was evidence of a weakness in the floor consistent with a direct hernia.It was reported that the patient underwent right inguinal hernia repair surgery on (b)(6) 2017 and mesh was implanted.It was reported that the patient experienced an unknown event.It was reported that the patient previously underwent hernia repair surgery on (b)(6) 2005 and mesh was implanted.Other procedure is captured in separate file.No additional information was provided.

Manufacturer Narrative

Date sent to the fda: (b)(6) 2020.Additional information: d4, h4.A review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.

• Brand Name: PROLENE MESH 3INX6IN
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08876
• Manufacturer (Section G): ETHICON INC.-SAN LORENZO PR; road 183, km 8.3; san lorenzo PR 00754 ; * 00754
• Manufacturer Contact: elba bello ; p.o. box 151, route 22 west; somerville, NJ 08876 ; 9082183429
• MDR Report Key: 10837143
• MDR Text Key: 216178315
• Report Number: 2210968-2020-09025
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 10705031049024
• UDI-Public: 10705031049024
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K180829
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 11/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2014
• Device Model Number: PMII
• Device Catalogue Number: PMII
• Device Lot Number: BEE879
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/02/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/15/2009
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 52 YR
• Patient Sex: Male