MAUDE Adverse Event Report: ETHICON INC. PVP MEDIUM 6.4CM X 6.4CM MESH, SURGICAL, POLYMERIC

Catalog Number PVPM

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/30/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4). The device history records were reviewed and the manufacturing criteria was met prior to the release of this lot. The following information was requested but unavailable: it was reported that an issue with the mesh was noted when the surgical staff opened the product during a hernia repair. Please provide the following: did the mesh fall apart upon removal of device from the package, was the mesh discolored, did the mesh tear during implantation? did the device come in contact with the patient prior to it being removed from the surgical field after opening the package? how was the procedure completed? confirm that there were no patient consequences? a ventral patch in opened folder and one empty opened foil of product code pvpm, lot kl8bwmb0 were returned for analysis. During visual inspection of the sample, body fluids on the ventral patch was noted; also, the two wings were partially detached. In addition, there are several fragments of the pds base plate present, indicating significant degradation. The manufacturing records were reviewed and the manufacturing/packaging criteria were met prior to the release of this batch. Due to the condition of the sample, no conclusion could be reached as to what may have caused the reported incident.

Event Description

It was reported that the patient underwent umbilical hernia procedure on (b)(6) 2018 and mesh was used. An unknown issue with the mesh was found when the package was opened. It is unknown if the issue was found during implantation or prior to implantation. There were no adverse patient consequences reported. Upon device evaluation, the wings were found partially detached. No additional information was provided.

• Brand Name: PVP MEDIUM 6.4CM X 6.4CM
• 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 GMBH; p.o. box 1409 d22841; norderstedt
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 7643231
• MDR Text Key: 112556652
• Report Number: 2210968-2018-73892
• 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
• Report Date: 06/08/2018

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 06/27/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 09/30/2018
• Device Catalogue Number: PVPM
• Device Lot Number: KL8BWMB0
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2018

Is the Reporter a Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 06/08/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2016
• Is the Device Single Use?: Yes

Is This a Reprocessed and Reused Single-Use Device?

• Type of Device Usage: Initial