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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. PROCEED VENTRAL PATCH::SIZE 4.3 X 4.3 CM MESH, SURGICAL, POLYMERIC

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ETHICON INC. PROCEED VENTRAL PATCH::SIZE 4.3 X 4.3 CM MESH, SURGICAL, POLYMERIC Back to Search Results
Catalog Number XCPVPS
Device Problem Material Separation (1562)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/05/2018
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 product upon which this medwatch is based has been received, however, the 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) 2018 and the mesh was implanted. During the procedure, the mesh fell apart during surgery. The mesh was recovered. Another like device was used to complete the procedure. There were no adverse consequences reported. No further information requested.
 
Manufacturer Narrative
Pc-(b)(4). Date sent to the fda: (b)(4) 2018. A used mesh of product code (b)(4), lot mb8bwtb0 was returned for analysis. During the visual inspection of device, body fluids were present, the straps were welded to the load ring correctly, however it was noted damaged (torn) on the final straps and the ethibond suture loop. The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch. Per the condition of the sample received, the assignable cause suggests an improper handling.
 
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Brand NamePROCEED VENTRAL PATCH::SIZE 4.3 X 4.3 CM
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
GM
Manufacturer Contact
darlene kyle
p.o. box 151, route 22 west
somerville, NJ 08876-0151
9082182792
MDR Report Key7931825
MDR Text Key122644481
Report Number2210968-2018-76293
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 09/05/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/03/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/31/2020
Device Catalogue NumberXCPVPS
Device Lot NumberMB8BWTB0
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/21/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/15/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/01/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

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