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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. VYPRO II MESH UND/VIO 15X10CM MESH, SURGICAL, POLYMERIC

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ETHICON INC. VYPRO II MESH UND/VIO 15X10CM MESH, SURGICAL, POLYMERIC Back to Search Results
Catalog Number PVM2N3
Device Problem Device Markings/Labelling Problem (2911)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/01/2017
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.

 
Event Description

It was reported that prior to any procedure, the package was found without origin label. There were no adverse consequences for the patient reported. No additional information was provided.

 
Manufacturer Narrative

Product complaint # (b)(4). It was reported that this device is not malfunction reportable. Therefore, this medwatch report is not reportable.

 
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Brand NameVYPRO II MESH UND/VIO 15X10CM
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
ETHICON INC.
p.o. box 151, route 22 west
somerville 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 08876-0151
9082182792
MDR Report Key7146193
MDR Text Key95926213
Report Number2210968-2017-71968
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
PMA/PMN NumberK002672
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 11/28/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/26/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Device Catalogue NumberPVM2N3
Device LOT NumberLK8CCMS0
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/09/2018
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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