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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 Detachment Of Device Component (1104)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/30/2018
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. The following information was requested but unavailable: it was reported that an issue with the mesh was noted when the surgical staff opened the product during a hernia repair. Please provide the following: did the mesh fall apart upon removal of device from the package, was the mesh discolored, did the mesh tear during implantation? did the device come in contact with the patient prior to it being removed from the surgical field after opening the package? how was the procedure completed? confirm that there were no patient consequences? a ventral patch in opened folder and one empty opened foil of product code pvpm, lot kl8bwmb0 were returned for analysis. During visual inspection of the sample, body fluids on the ventral patch was noted; also, the two wings were partially detached. In addition, there are several fragments of the pds base plate present, indicating significant degradation. The manufacturing records were reviewed and the manufacturing/packaging criteria were met prior to the release of this batch. Due to the condition of the sample, no conclusion could be reached as to what may have caused the reported incident.

 
Event Description

It was reported that the patient underwent umbilical hernia procedure on (b)(6) 2018 and mesh was used. An unknown issue with the mesh was found when the package was opened. It is unknown if the issue was found during implantation or prior to implantation. There were no adverse patient consequences reported. Upon device evaluation, the wings were found partially detached. No additional information was provided.

 
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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 Key7643231
MDR Text Key112556652
Report Number2210968-2018-73892
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK061533
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 06/08/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/27/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date09/30/2018
Device Catalogue NumberPVPM
Device LOT NumberKL8BWMB0
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer05/24/2018
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/08/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured10/01/2016
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

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