MAUDE Adverse Event Report: JOHNSON & JOHNSON INTERNATIONAL PROCEED VENTRAL PATCH MESH, SURGICAL, POLYMERIC

Catalog Number PVPM

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/10/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4). Date sent to the fda: 01/30/2017. In addition, a 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 product 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) 2017 and the mesh was implanted. During the procedure, when the mesh was positioned into place, one of the straps broke off when attempting to secure the device in place. The mesh was removed and another like device was used to complete the procedure with no patient consequences reported. No further information is available.

Manufacturer Narrative

The cause for the strap breaking off could not be determined. The used device presented one (blood contaminated) strap that had completely torn off. No wing detachment was observed at the device at the welding with the loadring. The other strap had partially torn off, showing detached wing at the welding with the loadring. The suture loops of both straps were intact and did not appear to have been utilized (for proper positioning in the patient body).

• Brand Name: PROCEED VENTRAL PATCH
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): JOHNSON & JOHNSON INTERNATIONAL; leonardo da vincilaan 15; diegem 1831 ; BE 1831
• Manufacturer (Section G): ETHICON INC.-GMBH; robert-koch strasse 1; norderstedt D-228 51; GM D-22851
• Manufacturer Contact: darlene kyle ; route 22 west po box 151; somerville, NJ 08876 ; 9082182792
• MDR Report Key: 6286488
• MDR Text Key: 66053688
• Report Number: 2210968-2017-60038
• 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: 01/17/2017

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 01/30/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 08/30/2018
• Device Catalogue Number: PVPM
• Device Lot Number: KK8CZJB0
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 02/06/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial