MASSAGER NM12

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 2016-01-06 for MASSAGER NM12 manufactured by Conair Corporation.

Event Text Entries

[35161644] We have requested the product back from the consumer but have not received to date. Device not returned to manufacturer.
Patient Sequence No: 1, Text Type: N, H10


[35161645] The consumer alleges that battery compartment in the device has melted. The consumers granddaughter's hand was slightly burned.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1222304-2016-00002
MDR Report Key5347610
Report SourceCONSUMER
Date Received2016-01-06
Date of Report2015-12-29
Date of Event2015-12-29
Date Added to Maude2016-01-06
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 NameMASSAGER
Generic NameMASSAGER
Product CodeISA
Date Received2016-01-06
Model NumberNM12
Device Availability*
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 2016-01-06

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