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

Catalog Number PVPM

Device Problem Delamination (2904)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/19/2017

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 seal area was examined visually and it was noted to be complete and no damaged or wrinkles were present.During the visual inspection, some degradation was observed as some of the components are absorbable.The foil was examined and multiple holes were observed on the wrinkles consistent with excessive manipulation or handling.Per the foil condition the assignable cause of the performance - delamination or fraying was a result of pin holes in the foil consistent with excessive manipulation resulting in a degradation of the mesh patch.

Event Description

It was reported that the patient underwent a hernia repair procedure on (b)(6) 2017 and the mesh was implanted.When a nurse opened the package, the mesh was falling apart/flaking off.The package integrity was reported to be okay.Another like device was used to complete the procedure.

• 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: 6791422
• MDR Text Key: 82666600
• Report Number: 2210968-2017-60386
• 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: health professional,user faci
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2017
• Device Catalogue Number: PVPM
• Device Lot Number: JM8DZQB0
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/24/2017
• Initial Date FDA Received: 08/14/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1