MAUDE Adverse Event Report: ETHICON INC. PROCEED*SURG MESH/MULTI LYR MESH, SURGICAL, POLYMERIC

Model Number PCDG1

Device Problem Peeled/Delaminated (1454)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/26/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4). A photo of the product upon which this medwatch is based has been received, however, the product evaluation is not yet complete. Any further information derived from the evaluation will be submitted in a supplemental 3500a form   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.   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 hernia repair procedure on (b)(6) 2021 and the mesh was used. It was found that the mesh was defective as the components separated visceral and parietal sides. It was reported that surgery was delayed by one hour. The procedure was successfully completed with a competitor device. There were no adverse patient consequences reported.

• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-CORNELIA; 655 ethicon circle; cornelia GA 30531
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 11715128
• MDR Text Key: 247060678
• Report Number: 2210968-2021-03702
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K060713
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility

Reporter Occupation

• Type of Report: Initial,Followup,Followup
• Report Date: 04/01/2022

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 04/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 09/30/2020
• Device Model Number: PCDG1
• Device Catalogue Number: PCDG1
• Device Lot Number: MKG236
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/03/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/13/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial