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

Catalog Number PVPM

Device Problem Material Frayed (1262)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/20/2017

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.To date the device has not been returned.If the device or further details are received at the later date a supplemental medwatch will be sent.Additional information was requested and the following was obtained: it was reported that a defect in the mesh near the bunny ears or pull up tags.Please provide the following: what exactly was wrong with the device were the tabs/wings detached from the rest of the mesh? the product specialist has advised that the surgeon described the issue as some kind of fraying.No further information has been made available.Confirm that the mesh did not have any contact with the patient? no patient contact.

Event Description

It was reported that the patient underwent an unknown procedure on (b)(6) 2017 and the mesh was implanted.The mesh was checked before implanting and a defect was found in the mesh near the bunny ears or pull up tags.The surgeon described the issue as some kind of fraying and there was no patient contact with the mesh.Another like device was used to complete the procedure.There were no adverse patient consequences reported.

Manufacturer Narrative

One open, used device, one empty tray and one empty opened foil were returned for evaluation.During the visual inspection of the sample, the tabs (pull up tags) were examined and could not be determined if any defects or damaged were present before the use.As the sample is an absorbable product and was returned opened, the degradation process has already begun.According to the sample condition delamination or fraying was observed.It could not be determined what may have caused the reported incident.

• 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: 6629564
• MDR Text Key: 77329262
• Report Number: 2210968-2017-60262
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K061533
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2018
• Device Catalogue Number: PVPM
• Device Lot Number: KD8CHBB0
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/09/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2016
• 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