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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 PVPM
Device Problem Detachment Of Device Component (1104)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/21/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4). In addition, a 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 a later date a supplemental medwatch will be sent. Additional information was requested and the following was obtained: please provide procedure name. Hernia repair. Were there any adverse patient consequences? no reported adverse consequences for patient.
 
Event Description
It was reported that the patient underwent a laparoscopic hernia repair procedure on (b)(6) 2016 and the mesh was implanted. During the procedure, the loop was pulled and came away so could not use it. The device was therefore insufficient for use and another like device was opened as this was removed laparoscopically. There were no adverse patient consequences reported.
 
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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 INC.-GMBH
robert-koch strasse 1
norderstedt D-228 51
GM D-22851
Manufacturer Contact
kenneth clark
route 22 westp o box 151
somerville, NJ 08876
9082183547
MDR Report Key5888647
MDR Text Key52512902
Report Number2210968-2016-11449
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K061533
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Reporter Occupation
Type of Report Initial
Report Date 08/01/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/19/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberPVPM
Device Lot NumberJE8CXQA0
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/29/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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