CONAIR SSPB10F

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2019-04-09 for CONAIR SSPB10F manufactured by Conair Corporation.

Event Text Entries

[141320371] On 04/09/2019 - we have requested the device be returned to the manufacturer. To date, we have not received the device.
Patient Sequence No: 1, Text Type: N, H10


[141320372] On (b)(6) 2019 - the consumer claims to have placed her hand in the wax and burnt her hand which caused redness and swelling. Medical attention was not received.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1222304-2019-00005
MDR Report Key8495196
Report SourceCONSUMER
Date Received2019-04-09
Date of Report2019-03-13
Date of Event2019-03-13
Date Added to Maude2019-04-09
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 FDA3
Event Location3
Manufacturer Street1 CUMMINGS POINT RD.
Manufacturer CitySTAMFORD,
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCONAIR
Generic NamePARRAFIN BATH
Product CodeIMC
Date Received2019-04-09
Model NumberSSPB10F
Device AvailabilityN
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerCONAIR CORPORATION
Manufacturer Address1 CUMMINGS POINT RD STAMFORD 06902 US 06902


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2019-04-09

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