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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MENTOR WORLDWIDE LLC OBTAPE

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MENTOR WORLDWIDE LLC OBTAPE Back to Search Results
Catalog Number 93-4000
Device Problem Insufficient Information (3190)
Patient Problem Injury (2348)
Event Date 12/08/2016
Event Type  Injury  
Manufacturer Narrative
Ni.
 
Event Description
Injuries.
 
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Type of DeviceOBTAPE
Manufacturer (Section D)
MENTOR WORLDWIDE LLC
33 technology drive
irvine CA 92618
Manufacturer (Section G)
MENTOR WORLDWIDE LLC
33 technology drive
irvine CA 92618
Manufacturer Contact
joaquin kurz
irvine, CA 92618
9497893837
MDR Report Key6172226
MDR Text Key62319552
Report Number1645337-2016-00234
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
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 12/08/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/13/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number93-4000
Other Device ID Number93-4000
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/13/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/08/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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