SKYTRON ST23

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2015-02-12 for SKYTRON ST23 manufactured by Dkk.

Event Text Entries

[16987490] (b)(6) hospital contacted distributor questioning lights causing 2nd degree burns. The operating room was shut down until the service technician could evaluate. The uv filters were not installed on the lights and may have contributed to burns on patient's dating back to (b)(6) 2014. The facility has been trained on the use of the uv filters but has since removed lights from their facility.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1825014-2014-00021
MDR Report Key4534105
Report Source99
Date Received2015-02-12
Date of Report2015-02-11
Date of Event2014-11-24
Date Facility Aware2014-01-12
Report Date2015-11-02
Date Reported to FDA2015-12-02
Date Reported to Mfgr2015-12-02
Date Added to Maude2015-02-24
Event Key0
Report Source CodeDistributor report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use0
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSKYTRON
Generic NameSURGICAL LIGHTS
Product CodeEBA
Date Received2015-02-12
Model NumberST23
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Age8 DA
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerDKK
Manufacturer AddressTOKYO JA


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization 2015-02-12

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