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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 05/14/2018
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.  .

 
Event Description

It was reported that the patient underwent hernia repair on (b)(6) 2018 and mesh was used. During the procedure, the tab tore off the device during surgery. There were no adverse patient consequences reported. No additional information was provided.

 
Manufacturer Narrative

Date sent to the fda: (b)(4) 2018. An empty opened foil and used mesh were returned for evaluation. During visual inspection of the sample, body fluids on the ventral patch was noted; also, the two wings were totally detached. In addition, there are several fragments of the pds base plate present, indicating significant degradation. Due to the condition of the sample, no conclusion could be reached.

 
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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 Key7606417
MDR Text Key111324876
Report Number2210968-2018-73505
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeAU
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 05/23/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/15/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date10/31/2019
Device Catalogue NumberPVPM
Device LOT NumberLM8DLJB0
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer06/08/2018
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/05/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured11/01/2017
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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