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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER SURGICAL ELECTRIC DERMATOME HANDPIECE
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ZIMMER SURGICAL ELECTRIC DERMATOME HANDPIECE Back to Search Results
Catalog Number 00-8821-001-00
Device Problem Device Stops Intermittently (1599)
Patient Problem No Information (3190)
Event Date 12/01/2013
Event Type  malfunction  
Event Description
It was reported that the zimmer electric dermatome was stopping/starting after doing nothing after initially upon turning the device on.No additional clinical information was received prior to this report.
 
Manufacturer Narrative
The device was returned to the manufacturer; however, the investigation was not completed at the time of this report.A follow up medwatch will be submitted once the investigation is complete.
 
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Brand Name
ELECTRIC DERMATOME HANDPIECE
Type of Device
ELECTRIC DERMATOME HANDPIECE
Manufacturer (Section D)
ZIMMER SURGICAL
200 west ohio ave.
dover OH 44622
Manufacturer Contact
kathleen smith
200 west ohio ave.
dover, OH 44622
3303438801
MDR Report Key3784385
MDR Text Key4439585
Report Number1526350-2014-00020
Device Sequence Number1
Product Code GFD
Combination Product (y/n)N
Reporter Country CodeAS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation Unknown
Type of Report Initial
Report Date 12/17/2013
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number00-8821-001-00
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer01/04/2014
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 12/17/2013
Initial Date FDA Received01/16/2014
Was Device Evaluated by Manufacturer? No
Date Device Manufactured03/01/2005
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Treatment
ZIMMER ELECTRIC DERMATOME POWER SUPPLY; 00-8821-006-00, SN# (B)(4)
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