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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO MICRODRILL SERIES STRAIGHT ATTACHMENT UNIT, OPERATIVE DENTAL

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STRYKER INSTRUMENTS-KALAMAZOO MICRODRILL SERIES STRAIGHT ATTACHMENT UNIT, OPERATIVE DENTAL Back to Search Results
Catalog Number 5100015250
Device Problem Overheating of Device (1437)
Patient Problem Burn(s) (1757)
Event Date 08/15/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
The user facility reported the device overheated and burned the patient on the lower right side of their lip during a procedure. Although requested, there was no information available regarding burn severity, delay, medical intervention, and adverse consequences.
 
Manufacturer Narrative
The device was not returned for evaluation; therefore, a root cause could not be determined for the event.
 
Event Description
The user facility reported the device overheated and burned the patient on the lower right side of their lip during a procedure. Although requested, there was no information available regarding burn severity, delay, medical intervention, and adverse consequences.
 
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Brand NameMICRODRILL SERIES STRAIGHT ATTACHMENT
Type of DeviceUNIT, OPERATIVE DENTAL
Manufacturer (Section D)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
MDR Report Key8047776
MDR Text Key126532607
Report Number0001811755-2018-02388
Device Sequence Number1
Product Code EIA
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Type of Report Initial,Followup
Report Date 05/15/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/07/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number5100015250
Device Lot Number08201835
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/10/2018
Is This a Reprocessed and Reused Single-Use Device? No

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