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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER SURGICAL, INC. ZIMMER AIR DERMATOME
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ZIMMER SURGICAL, INC. ZIMMER AIR DERMATOME Back to Search Results
Model Number N/A
Device Problem Intermittent Loss of Power (4016)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
This event has been recorded by zimmer biomet under (b)(4).Once an evaluation of this device is completed, a follow-up/final report will be submitted.Telephone number: (b)(6).
 
Event Description
It was reported that the device gets blocked during use.No further information provided.No adverse events have been reported as a result of this malfunction.
 
Manufacturer Narrative
It was discovered that this complaint ((b)(4)) is a duplicate of another complaint in our system, (b)(4).Please disregard the previously submitted report, as it is a duplicate.The correct reports with this information can be found under report ids 0001526350-2020-00917 & 0001526350-2020-00917-1.
 
Event Description
It was discovered that this complaint ((b)(4)) is a duplicate of another complaint in our system, (b)(4).Please disregard the previously submitted report, as it is a duplicate.The correct reports with this information can be found under report ids 0001526350-2020-00917 & 0001526350-2020-00917-1.
 
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Brand Name
ZIMMER AIR DERMATOME
Type of Device
DERMATOME
Manufacturer (Section D)
ZIMMER SURGICAL, INC.
200 west ohio avenue
dover OH 44622
MDR Report Key10785774
MDR Text Key214574128
Report Number0001526350-2020-00926
Device Sequence Number1
Product Code GFD
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Type of Report Initial,Followup
Report Date 11/04/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/04/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue Number00880100100
Was the Report Sent to FDA? No
Date Manufacturer Received12/31/2020
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
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