CONAIR

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 2016-10-17 for CONAIR manufactured by Conair Corporation.

Event Text Entries

[57583339] On 10/14/2016 - we have requested the product be returned to the manufacturer. To date, we have not received the product.
Patient Sequence No: 1, Text Type: N, H10


[57583340] On 10/4/2016 - the consumer alleges to have received a burn on his arm with in use the product.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1222304-2016-00039
MDR Report Key6033136
Report SourceCONSUMER
Date Received2016-10-17
Date of Report2016-09-29
Date of Event2016-09-28
Date Added to Maude2016-10-17
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
Generic NameMASSAGER
Product CodeISA
Date Received2016-10-17
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 2016-10-17

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