• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ETHICON INC. PROCEED VENTRAL PATCH MESH, SURGICAL, POLYMERIC Back to Search Results
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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePROCEED VENTRAL PATCH
Type of DeviceMESH, 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 Key5389120
MDR Text Key36804996
Report Number2210968-2016-02639
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K061533
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/31/2015
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/25/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/30/2017
Device Catalogue NumberPVPS
Device Lot NumberJH8GZRA0
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/20/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received02/03/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/01/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-