HAND/FOOT II UAB-128

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1996-01-18 for HAND/FOOT II UAB-128 manufactured by National Biological Corp..

Event Text Entries

[16403] Pt inadvertently received both uva and uvb during hand photo therapy. Uva was ordered.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number29940
MDR Report Key29940
Date Received1996-01-18
Date of Report1995-07-18
Date of Event1995-06-21
Date Facility Aware1995-06-22
Report Date1995-07-05
Date Reported to Mfgr1995-07-18
Date Added to Maude1996-02-13
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Reporter OccupationRISK MANAGER
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameHAND/FOOT II
Generic NamePHOTO THERAPY
Product CodeKGL
Date Received1996-01-18
Model NumberUAB-128
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Age3 MO
Implant FlagN
Date RemovedB
Device Sequence No1
Device Event Key31035
ManufacturerNATIONAL BIOLOGICAL CORP.
Manufacturer Address1532 ENTERPRISE PKWY TWINSBURG OH 44087 US


Patients

Patient NumberTreatmentOutcomeDate
101. Other 1996-01-18

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