LEE'S *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2002-04-12 for LEE'S * manufactured by Lee's Candles Inc.

Event Text Entries

[19488333] Rptr is giving the source of ear wax candles. Rptr has no complaint other than that ear wax candles are dangerous to use.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW4003288
MDR Report Key396380
Date Received2002-04-12
Date Added to Maude2002-05-29
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Reporter OccupationPATIENT
Health Professional3
Initial Report to FDA0
Report to FDA3
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameLEE'S
Generic NameEAR CANDLES
Product CodeJYH
Date Received2002-04-12
Model Number*
Catalog Number*
Lot NumberNA
ID Number*
Device Availability*
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key385409
ManufacturerLEE'S CANDLES INC
Manufacturer Address5734 SKY COUNTY SAN ANTONIO TX 78247 US


Patients

Patient NumberTreatmentOutcomeDate
10 2002-04-12

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