SLENDERTONE FACE 371 0371-2054

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,foreign report with the FDA on 2016-01-21 for SLENDERTONE FACE 371 0371-2054 manufactured by Bio-medical Research Ltd.

Event Text Entries

[36468083] Consumer reported a rash after using her face unit for 3 months. She suffers from allergies and cannot use scented products or perfumes on her skin. She assumes she may be allergic to the pads. The device was returned to the place of purchase and the serial number was not available, therefore no evaluation of the device or it device history record could be completed. Upon retrospective review, this issue was determined to be reportable as an mdr. Device was returned to place of purchase.
Patient Sequence No: 1, Text Type: N, H10


[36468084] Consumer only used the device once or twice a week due to known history of allergies. After 3 months of use she reported rash burns on her skin. She used hydrocortisone cream and eumovate ointment prescribed by her doctor on previous occasions for other events not related to the use of slendertone devices. She did not see a doctor for this event.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number8020867-2015-00017
MDR Report Key5382442
Report SourceCONSUMER,FOREIGN
Date Received2016-01-21
Date of Report2013-01-15
Date of Event2013-01-08
Date Added to Maude2016-01-21
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 ContactMS ANDREA SMALL
Manufacturer StreetPARKMORE BUSINESS PARK WEST GALWAY
Manufacturer CityGALWAY, H91 NHT7
Manufacturer CountryEI
Manufacturer PostalH91 NHT7
Manufacturer Phone91774350
Manufacturer G1BIO-MEDICAL RESEARCH LTD
Manufacturer StreetPARKMORE BUSINESS PARK WEST GALWAY
Manufacturer CityGALWAY, H91-NHT7
Manufacturer CountryEI
Manufacturer Postal CodeH91-NHT7
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSLENDERTONE FACE
Generic NamePOWERED MUSCLE STIMULATOR
Product CodeNGX
Date Received2016-01-21
Model Number371
Catalog Number0371-2054
OperatorLAY USER/PATIENT
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerBIO-MEDICAL RESEARCH LTD
Manufacturer AddressPARKMORE BUSINESS PARK WEST GALWAY GALWAY, H91-NHT7 EI H91-NHT7


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2016-01-21

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