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

Model Number PCDH1

Device Problem Material Split, Cut or Torn (4008)

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

Event Date 03/22/2021

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4). Photos of the product upon which this medwatch is based have 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 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 on (b)(6) 2021 and the mesh was implanted. It was reported that there was a tearing up of the device at the site where the device was fixated. It was also reported that the surgery was delayed for fifteen minutes. It was reported that the procedure was successfully completed with the same mesh and absorbable straps to repair the mesh. It was also reported that the surgeon is expecting a recurrence of hernia as a result of the mesh tearing. 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: 11701007
• MDR Text Key: 246760922
• Report Number: 2210968-2021-03585
• 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: company representative,foreig

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 03/22/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 04/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 07/31/2021
• Device Model Number: PCDH1
• Device Catalogue Number: PCDH1
• Device Lot Number: PJG130
• 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: 08/11/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/21/2019
• Is the Device Single Use?: Yes

Is This a Reprocessed and Reused Single-Use Device?

• Type of Device Usage: Initial