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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO MD SERIES LONG STRAIGHT ATTACHMENT; UNIT, OPERATIVE DENTAL
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STRYKER INSTRUMENTS-KALAMAZOO MD SERIES LONG STRAIGHT ATTACHMENT; UNIT, OPERATIVE DENTAL Back to Search Results
Model Number 5100015270
Device Problem Overheating of Device (1437)
Patient Problems Burn(s) (1757); Partial thickness (Second Degree) Burn (2694); Full thickness (Third Degree) Burn (2696)
Event Date 06/19/2019
Event Type  Injury  
Event Description
The user facility reported the device overheated during a procedure, which lead to second and third degree burns incurred by the patient.Although requested, information regarding surgical delay, medical intervention, or if the procedure was completed successfully is unknown.
 
Manufacturer Narrative
Device evaluation: follow-up report submitted to document device evaluation results.
 
Event Description
The user facility reported the device overheated during a procedure, which lead to second and third degree burns incurred by the patient.Although requested, information regarding surgical delay, medical intervention, or if the procedure was completed successfully is unknown.
 
Manufacturer Narrative
Correction: this correction is being filed to update outcomes attributed to problem & adverse event.
 
Event Description
The user facility reported the device overheated during a procedure, which lead to second and third degree burns incurred by the patient.Although requested, information regarding surgical delay, medical intervention, or if the procedure was completed successfully is unknown.
 
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Brand Name
MD SERIES LONG STRAIGHT ATTACHMENT
Type of Device
UNIT, OPERATIVE DENTAL
Manufacturer (Section D)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
MDR Report Key8826976
MDR Text Key152208487
Report Number0001811755-2019-02568
Device Sequence Number1
Product Code EIA
UDI-Device Identifier04546540380289
UDI-Public04546540380289
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup,Followup
Report Date 11/30/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/25/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model Number5100015270
Device Catalogue Number5100015270
Device Lot Number18248
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/22/2019
Date Manufacturer Received11/28/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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