BMS3WT - MASSAGER

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 2015-10-27 for BMS3WT - MASSAGER manufactured by Conair Corporation.

Event Text Entries

[29323571] The device is no longer sold and has not been supplied in the us for approximately 15 years. Within the past 20 years, this is the second alleged malfunction received for this product. Device not submitted to manufacturer.
Patient Sequence No: 1, Text Type: N, H10


[29323572] Consumer alleges to have received 2nd degree burns from laying on the massager for her back, but she received the burn on her left hip back area. She claims to have received medical attention and that the er has given her pain medications and creams. She claims to have severe depression and anxiety from this incident.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1222304-2015-00022
MDR Report Key5180092
Report SourceCONSUMER
Date Received2015-10-27
Date of Report2015-10-08
Date of Event2015-10-05
Date Mfgr Received2015-10-08
Date Added to Maude2015-10-27
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 CT 06902
Manufacturer CountryUS
Manufacturer Postal06902
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameBMS3WT - MASSAGER
Generic NameMASSAGER
Product CodeISA
Date Received2015-10-27
Model NumberBMS3WT
Device AvailabilityN
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerCONAIR CORPORATION
Manufacturer Address1 CUMMINGS POINT RD STAMFORD CT 06902 US 06902


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2015-10-27

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