CONAIR MASSAGER WM52CS

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 2016-05-17 for CONAIR MASSAGER WM52CS manufactured by Conair Corporation.

Event Text Entries

[45320143] On (b)(6) 2016 - we have requested the device be returned to the manufacturer for evaluation. To date, we have not received the device.
Patient Sequence No: 1, Text Type: N, H10


[45320144] On (b)(6) 2016 - the consumer alleges to have received a burn. The consumer admittingly fell asleep while in use of this product. The consumer claims to have a severe burn on stomach. Medical attention to be received.
Patient Sequence No: 1, Text Type: D, B5


[47608706] On 4/28/2016 - we have requested the device be returned to the manufacturer for evaluation. To date, we have not received the device. On 5/17/2016 - device has been received and is currently under evaluation. On 6/16/2016 - per manufacturers report, temperature and electrical testing was conducted and within the specifications. Per the original report, the consumer admittlingly fell asleep while in use of the product. Laying or sleeping while in use of the product is not recommended per the ib.
Patient Sequence No: 1, Text Type: N, H10


[47608707] On (b)(6) 2016 - the consumer alleges to have received a burn. The consumer admittingly fell as sleep while in use of this product. The consumer claims to have a severe burn on stomach. Medical attention to be received.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1222304-2016-00023
MDR Report Key5659384
Report SourceCONSUMER
Date Received2016-05-17
Date of Report2016-04-22
Date of Event2016-04-20
Date Added to Maude2016-05-17
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 NameCONAIR MASSAGER
Generic NameMASSAGER
Product CodeISA
Date Received2016-05-17
Model NumberWM52CS
Device Availability*
Device AgeDA
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 2016-05-17

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