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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 PVPS
Device Problem Detachment Of Device Component (1104)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/07/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Conclusion: to date, the device has not been returned. If the product is returned for evaluation, any further info derived from the evaluation will be submitted in a supplemental 3500a form.
 
Event Description
It was reported that a patient underwent an umbilical hernia repair on an unknown date and mesh was used. The absorbable deployment technology released from the mesh. Another like device was used to complete the procedure. There were no adverse patient consequences.
 
Manufacturer Narrative
Date sent to fda: 04/11/2016. In addition, a review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.
 
Manufacturer Narrative
The actual device presented used, blood contaminated condition. Both straps including suture loops were not present and appear to have been cut off at approx. 1-2 cm length. The wings of the device had partially separated on both sides at the welding with the load ring due to device handling. This may occur during handling and does not have any effect on the product properties and functionality.
 
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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
guillermo villa
route 22 west po box 151
somerville, NJ 08876
9082180707
MDR Report Key5526393
MDR Text Key41181108
Report Number2210968-2016-07125
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodePO
PMA/PMN Number
K061533
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 03/08/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/25/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/30/2017
Device Catalogue NumberPVPS
Device Lot NumberJLK8HBBB0
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/30/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received03/31/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/01/2015
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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