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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: JOHNSON & JOHNSON INTERNATIONAL PROCEED VENTRAL PATCH MESH, SURGICAL, POLYMERIC

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JOHNSON & JOHNSON INTERNATIONAL PROCEED VENTRAL PATCH MESH, SURGICAL, POLYMERIC Back to Search Results
Catalog Number XCPVPS
Device Problem Detachment Of Device Component (1104)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/26/2017
Event Type  malfunction  
Manufacturer Narrative
During investigation the whole pvp started to separate into their components due to initially disintegrated absorbable part of the mesh. This is to be expected when exposing to air humidity over a period of more than 11 weeks (alert date and event date is (b)(6) 2017). The cause of the strap breakage could not be determined. The partial separation of the wings at the welding with the load ring may occur during handling and does not have any effect on the product properties and functionality.
 
Manufacturer Narrative
(b)(4). The device history records were reviewed and the manufacturing criteria was met prior to the release of this lot. 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 repair on (b)(6) 2017 and mesh was used. When mesh was deployed into defect and pulled up, one of the tags detached from the mesh. Another like device was opened and the surgery proceeded without incident. There was a 5-minute delay to the surgery. There were no adverse patient consequences reported. No additional information has been provided.
 
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Brand NamePROCEED VENTRAL PATCH
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
JOHNSON & JOHNSON INTERNATIONAL
leonardo da vincilaan 15
diegem 1831
BE 1831
Manufacturer (Section G)
ETHICON INC.-GMBH
robert-koch strasse 1
norderstedt D-228 51
GM D-22851
Manufacturer Contact
darlene kyle
route 22 west po box 151
somerville, NJ 08876
9082182792
MDR Report Key6646397
MDR Text Key105436367
Report Number2210968-2017-60275
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeAS
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 05/26/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/16/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/31/2018
Device Catalogue NumberXCPVPS
Device Lot NumberKK8DSQB0
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/06/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received07/06/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/01/2016
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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