DEWRAP 46-333

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2008-09-18 for DEWRAP 46-333 manufactured by Deroyal Industries.

Event Text Entries

[956299] Bilateral lower extremities wrapped in dewrap for ulcerations on right and edema on left - developed rash.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5008343
MDR Report Key1167269
Date Received2008-09-18
Date of Report2008-09-18
Date of Event2008-08-25
Date Added to Maude2008-09-26
Event Key0
Report Source CodeVoluntary 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 FDA0
Event Location0
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameDEWRAP
Generic NameCOMPRESSION BANDAGE
Product CodeMHW
Date Received2008-09-18
Model Number46-333
Catalog Number46-333
Lot NumberUNK
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Implant FlagN
Date RemovedB
Device Sequence No1
Device Event Key1201168
ManufacturerDEROYAL INDUSTRIES


Patients

Patient NumberTreatmentOutcomeDate
10 2008-09-18

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