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U.S. Department of Health and Human Services

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

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ETHICON INC. PROCEED VENTRAL PATCH MESH, SURGICAL, POLYMERIC Back to Search Results
Catalog Number PVPM1
Device Problem Detachment Of Device Component (1104)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/01/2018
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). Attempts are being made to retrieve the device. To date the device has not been returned. If the device or further details are received at a later date a supplemental medwatch will be sent.

 
Event Description

It was reported that the patient underwent umbilical hernia procedure on (b)(6) 2018 and mesh was used. During the procedure, the tail piece fell off before it was implanted. No piece fell in to the patient. The procedure was completed with another mesh of the same product code. There were no adverse patient consequences reported.

 
Manufacturer Narrative

The device history records were reviewed and the manufacturing criteria was met prior to the release of this lot.

 
Manufacturer Narrative

During visual inspection of the sample, body fluids on the mesh was noted; also, the two wings were broken. In addition, there are several fragments of the base plate present, indicating significant degradation. The manufacturing records were reviewed and the manufacturing/packaging criteria were met prior to the release of this batch. Due to the condition of the sample, no conclusion could be reached as to what may have caused the reported incident.

 
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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 GMBH
p.o. box 1409 d22841
norderstedt
Manufacturer Contact
darlene kyle
p.o. box 151, route 22 west
somerville, NJ 08876-0151
9082182792
MDR Report Key7430832
MDR Text Key105712696
Report Number2210968-2018-72142
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK061533
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL,USER FACI
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 03/26/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received04/13/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date09/30/2019
Device Catalogue NumberPVPM1
Device LOT NumberLL8DBHB0
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer04/12/2018
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/16/2018
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured10/01/2017
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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