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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 07/24/2017
Event Type  Injury  
Event Description
The user facility reported that the patient was burned on the bottom left lip during a maxillofacial surgery to extract a molar.Petroleum jelly was used on the burn after the incident.The patient used at home, furacin antibiotic cream and petroleum jelly as directed by the doctor.
 
Event Description
The user facility reported that the patient was burned on the bottom left lip during a maxillofacial surgery to extract a molar.Petroleum jelly was used on the burn after the incident.The patient used at home, furacin antibiotic cream and petroleum jelly as directed by the doctor.
 
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Brand Name
MICRODRILL SERIES STRAIGHT ATTACHMENT
Type of Device
UNIT, OPERATIVE DENTAL
Manufacturer (Section D)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
Manufacturer (Section G)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
Manufacturer Contact
zach baker
4100 east milham avenue
kalamazoo, MI 49001
2693237700
MDR Report Key7938980
MDR Text Key122849304
Report Number0001811755-2018-01722
Device Sequence Number1
Product Code EIA
UDI-Device Identifier04546540380272
UDI-Public04546540380272
Combination Product (y/n)N
Reporter Country CodeES
PMA/PMN Number
K032117
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 12/13/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number5100015250
Device Lot Number15162
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/01/2018
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 09/10/2018
Initial Date FDA Received10/05/2018
Supplement Dates Manufacturer Received12/04/2018
Supplement Dates FDA Received12/13/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/11/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Outcome(s) Other;
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