MAUDE Adverse Event Report: ETHICON INC. PROCEED VENTRAL PATCH; MESH, SURGICAL, POLYMERIC

Catalog Number PVPS

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/30/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4): 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 umbilical hernia repair procedure on (b)(6) 2015 and mesh was implanted.During the procedure, the mesh tabs came off prematurely and they were unable to secure the mesh in place.The mesh was removed using instrumentation and the repair was completed using a new like device.There were no adverse patient consequences reported.

Manufacturer Narrative

Conclusion: the actual device was returned for evaluation and showed one strap was partially broken off and the other one was completely broke off at the load ring.The cause of strap breakage could not be clarified.It seems that the manipulation of the suture loop to facilitate proper positioning of the patch had not been used because no manipulation signs at the suture loop fixation point at both straps are visible.In addition, a review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.

• Brand Name: PROCEED VENTRAL PATCH
• 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 D-228 51; GM D-22851
• Manufacturer Contact: guillermo villa ; route 22 west po box 151; somerville, NJ 08876 ; 9082180707
• MDR Report Key: 5389120
• MDR Text Key: 36804996
• Report Number: 2210968-2016-02639
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 12/31/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2017
• Device Catalogue Number: PVPS
• Device Lot Number: JH8GZRA0
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2016
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/03/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2015
• 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