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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
Catalog Number PVPM
Device Problem Material Frayed (1262)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/29/2019
Event Type  malfunction  
Manufacturer Narrative
Product complaint #: (b)(4). A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified. 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 a patient underwent a ventral hernia repair on (b)(6) 2019 and the mesh was implanted. It was reported that during surgery the device disintegrated as it was being placed into the patient, "it just fell apart. " it was also reported that the packaging was intact. No fragments were left in the patient. A like device was used to complete the procedure. 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 0151
Manufacturer (Section G)
ETHICON INC.-GMBH
robert-koch strasse 1
22851
GM 22851
Manufacturer Contact
kara ditty-bovard
p.o. box 151, route 22 west
somerville, NJ 08876-0151
6107428552
MDR Report Key8930948
MDR Text Key155643655
Report Number2210968-2019-86157
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K061533
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/30/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/26/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/31/2020
Device Catalogue NumberPVPM
Device Lot NumberMJ8BSLB0
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/12/2019
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/12/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/01/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

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