UNK *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-01-27 for UNK * manufactured by Unk.

Event Text Entries

[18147756] Pt received a puva treatment (ongoing for 2. 5 years). Something either was wrong with what tech entered or machine is defective. It resulted in pt having 2nd degree burns on their entire body except hands and feet.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW1030943
MDR Report Key509218
Date Received2004-01-27
Date of Report2004-01-27
Date of Event2003-12-10
Date Added to Maude2004-02-03
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationPATIENT
Health Professional3
Initial Report to FDA0
Report to FDA0
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameUNK
Generic NamePUVA
Product CodeFTC
Date Received2004-01-27
Model Number*
Catalog Number*
Lot Number*
ID Number*
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key498174
ManufacturerUNK
Manufacturer AddressUNK UNK *


Patients

Patient NumberTreatmentOutcomeDate
101. Life Threatening; 2. Deathisabilit 2004-01-27

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