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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. PVP SMALL 4.3CM X 4.3CM MESH, SURGICAL, POLYMERIC

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ETHICON INC. PVP SMALL 4.3CM X 4.3CM MESH, SURGICAL, POLYMERIC Back to Search Results
Catalog Number PVPS
Device Problem Material Puncture/Hole (1504)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/14/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4). To date the device has not been returned. If the device or further details are received at the later date a supplemental medwatch will be sent.
 
Event Description
It was reported that the patient underwent a hernia repair procedure on (b)(6) 2018 and the mesh was implanted. Upon laying the mesh, it split apart. There were no patient consequences reported. Another like device was used to complete the procedure.
 
Manufacturer Narrative
(b)(4). Additional information: the device history records were reviewed and the manufacturing criteria was met prior to the release of this lot. An empty opened foil of product code pvps, lot ma8dltb0 was returned for analysis. The patch ventral proceed was not received. As no device was returned for evaluation, we are unable to investigate further to the issue.
 
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Brand NamePVP SMALL 4.3CM X 4.3CM
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 Key7719071
MDR Text Key115066839
Report Number2210968-2018-74620
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K061533
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/28/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/25/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/31/2019
Device Catalogue NumberPVPS
Device Lot NumberMA8DLTB0
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/31/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/31/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/01/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

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