WATER FALL FB52K

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2013-12-30 for WATER FALL FB52K manufactured by Conair Corp..

Event Text Entries

[21657784] Customer filled the unit with water and plugged it in the wall. Twenty seconds later, it shocked him. He was shocked when he pressed the light and heat button.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1222304-2013-00013
MDR Report Key3576809
Report Source04
Date Received2013-12-30
Date of Report2013-08-11
Date of Event2013-08-10
Date Mfgr Received2013-08-11
Date Added to Maude2014-01-28
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
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
Manufacturer Street1 CUMMINGS POINT RD.
Manufacturer CitySTAMFORD CT 06902
Manufacturer CountryUS
Manufacturer Postal06902
Manufacturer Phone2033519469
Single Use0
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameWATER FALL
Generic NameFOOT BATH
Product CodeISA
Date Received2013-12-30
Model NumberFB52K
OperatorLAY USER/PATIENT
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerCONAIR CORP.
Manufacturer AddressSTAMFORD CT US


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2013-12-30

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