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 09/06/2018

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. Additional information was requested, and the following was obtained: it was noted that the device came apart during insertion. Please indicate what portion of the device fell apart ie was it the white tabs, the body of the mesh or blue suture attached to the tabs that "fell apart"? sales rep. He is not sure, the facility staff just indicated that the device fell apart during insertion. Sales rep. Reported that the customer has the device and will be returning it upon receipt of the shipper kit. Was there any damage to the packaging ie packaging open, was the packaging pierced allowing the device to be exposed to the air/environment? sales rep. Reported that there was not reported issue with the packaging, only the mesh which fell apart during insertion.

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, while inserting the device it came apart. Another like device was used to complete the procedure. There were no adverse consequences reported.

Manufacturer Narrative

Pc-(b)(4). An empty opened foil, a ventral patch of product code (b)(4), lot # lm8bqmb0 were returned for analysis. During visual inspection of the sample, body fluids on the sample were noted; the ventral patch has begun with degradation process and there are several fragments of the pds base plate present. In addition, both wings were partially detached due to the degradation of the sample. In the visual inspection of opened foil, showed excessive manipulation and multiples holes on the wrinkles consistent with excessive manipulation. The seal area was examined visually, and it was noted to be complete and no damaged or wrinkles were present. Per the foil condition the assignable cause of the performance - loss of integrity - intra op was a result of pin holes in the foil consistent with excessive manipulation resulting in a degradation of the mesh ventral patch.

• 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: 7936460
• MDR Text Key: 123383881
• Report Number: 2210968-2018-76331
• 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: 09/12/2018

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 10/04/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 10/31/2019
• Device Catalogue Number: XCPVPS
• Device Lot Number: LM8BQMB0
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2018
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 10/17/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2017
• Is the Device Single Use?: Yes

Is This a Reprocessed and Reused Single-Use Device?

• Type of Device Usage: Initial