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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 Separation (1562)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/01/2018
Event Type  Malfunction  
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 an unknown procedure on an unknown date and mesh was used. During the procedure, at the moment of use, the surgeon noted the device to be ripped. There were no adverse patient consequences reported. No additional information was provided.

 
Manufacturer Narrative

Date sent to the fda: (b)(4) 2018. Additional summary: an empty opened foil and a used ventral patch of product code pvpm, lot ll8drzb0 were returned for analysis. During visual inspection of the sample, the ventral patch has begun with degradation process and there are several fragments of the pds base plate present. Also, the wings were partially detached. Per the condition of sample received, it could not be determined what may have caused the reported incident.

 
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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 GMBH
p.o. box 1409 d22841
norderstedt
Manufacturer Contact
darlene kyle
p.o. box 151, route 22 west
somerville, NJ 08876-0151
9082182792
MDR Report Key7598140
MDR Text Key111007975
Report Number2210968-2018-73464
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 05/21/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/13/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Device EXPIRATION Date09/30/2019
Device Catalogue NumberPVPM
Device LOT NumberLL8DRZB0
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer08/13/2018
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/13/2018
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured01/10/2017
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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