RELIEF BAND *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2000-01-12 for RELIEF BAND * manufactured by Woodside Biomedical.

Event Text Entries

[145862] Raised red skin irritation from the metal on the wristband.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW1017922
MDR Report Key258618
Date Received2000-01-12
Date of Report2000-01-12
Date of Event1999-12-23
Date Added to Maude2000-01-19
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA0
Report to FDA0
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameRELIEF BAND
Generic NameELECTRICAL STIMULATION WRISTBAND
Product CodeBWK
Date Received2000-01-12
Model Number*
Catalog Number*
Lot NumberB9911A3
ID Number*
OperatorLAY USER/PATIENT
Device AvailabilityR
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key250447
ManufacturerWOODSIDE BIOMEDICAL
Manufacturer Address1915 ASTON AVE. SUITE 102 CARLSBAD CA 92008 US


Patients

Patient NumberTreatmentOutcomeDate
10 2000-01-12

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