MAUDE Adverse Event Report: ETHICON INC. PROCEED VENTRAL PATCH::SIZE 4.3 X 4.3 CM MESH, SURGICAL, POLYMERIC

Catalog Number XCPVPS

Device Problem Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/05/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4). The review of the batch manufacturing records was conducted, and the batch met all finished goods release criteria. The product upon which this medwatch is based has been received, however, the evaluation is not yet complete. Any further information derived from the evaluation will be submitted in a supplemental 3500a form.

Event Description

It was reported that the patient underwent an umbilical hernia repair procedure on (b)(6) 2018 and the mesh was implanted. During the procedure, the mesh fell apart during surgery. The mesh was recovered. Another like device was used to complete the procedure. There were no adverse consequences reported. No further information requested.

Manufacturer Narrative

Pc-(b)(4). Date sent to the fda: (b)(4) 2018. A used mesh of product code (b)(4), lot mb8bwtb0 was returned for analysis. During the visual inspection of device, body fluids were present, the straps were welded to the load ring correctly, however it was noted damaged (torn) on the final straps and the ethibond suture loop. The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch. Per the condition of the sample received, the assignable cause suggests an improper handling.

• Brand Name: PROCEED VENTRAL PATCH::SIZE 4.3 X 4.3 CM
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer (Section G): ETHICON INC.-GMBH; robert-koch strasse 1; norderstedt ; GM
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 7931825
• MDR Text Key: 122644481
• Report Number: 2210968-2018-76293
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K061533
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 09/05/2018

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 10/03/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 01/31/2020
• Device Catalogue Number: XCPVPS
• Device Lot Number: MB8BWTB0
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2018
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 10/15/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2018
• Is the Device Single Use?: Yes

Is This a Reprocessed and Reused Single-Use Device?

• Type of Device Usage: Initial