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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. PVP MEDIUM 6.4CM X 6.4CM MESH, SURGICAL, POLYMERIC

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ETHICON INC. PVP MEDIUM 6.4CM X 6.4CM MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number PVPM
Device Problem Material Separation (1562)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/10/2020
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). 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. If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

 
Event Description

It was reported that a patient underwent an umbilical hernia repair on (b)(6) 2020 and the mesh was used. It was reported that after the placement of the pvpm, the surgeon was pulling out the two blindfolds out of the patient, one of the two has partially detached. It was reported that the device was partially defective and the blindfolds detached with a minimum strain. It was also reported that the device was then removed from the patient. It was reported that the physician put away the product and continued with sutures stitches. The surgery was delayed for 15 minutes due to the reported event. The procedure was successfully completed. There were no adverse patient consequences reported.

 
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Brand NamePVP MEDIUM 6.4CM X 6.4CM
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
ETHICON INC.
p.o. box 151, route 22 west
somerville NJ 08876
Manufacturer (Section G)
ETHICON INC.-GMBH
robert-koch strasse 1
norderstedt
GM
Manufacturer Contact
elba bello
p.o. box 151, route 22 west
somerville, NJ 08876
9082183429
MDR Report Key10311908
MDR Text Key199986805
Report Number2210968-2020-05489
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeIT
PMA/PMN NumberK061533
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/16/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/22/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date03/31/2021
Device MODEL NumberPVPM
Device Catalogue NumberPVPM
Device LOT NumberPDBCLSB0
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer08/06/2020
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/06/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured04/10/2019
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

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