SLENDERTONE ULTRA 0517 0517-5000

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 2015-12-09 for SLENDERTONE ULTRA 0517 0517-5000 manufactured by Bio-medical Research Ltd..

Event Text Entries

[32975639] No action taken as customer did not return product for investigation and on 11. 11. 14 the customer requested that we close out the complaint. Note no medical report or other evidence was supplied by the customer. The slendertone ultra ifu provides the following information contact slendertone if: you experience any irritation, skin reaction, hypersensitivity, or other adverse reaction.
Patient Sequence No: 1, Text Type: N, H10


[32975640] The customer experienced discomfort and sores/puss from sores on skin. The customer went to doctor and was told that he was allergic to gel pads. The customer has not used the belt since.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number8020867-2015-00005
MDR Report Key5276521
Report SourceCONSUMER
Date Received2015-12-09
Date of Report2014-08-29
Date of Event2014-08-29
Date Mfgr Received2014-08-29
Device Manufacturer Date2013-07-19
Date Added to Maude2015-12-09
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 ANNE-MARIE KEENAN
Manufacturer StreetPARKMORE BUSINESS PARK WEST
Manufacturer CityGALWAY, H91 NHT7
Manufacturer CountryEI
Manufacturer PostalH91 NHT7
Manufacturer Phone91774316
Manufacturer G1BIO-MEDICAL RESEARCH LTD.
Manufacturer StreetPARKMORE BUSINESS PARK WEST
Manufacturer CityGALWAY, H91 NHT7
Manufacturer CountryEI
Manufacturer Postal CodeH91 NHT7
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSLENDERTONE ULTRA
Generic NamePOWERED MUSCLE STIMULATOR
Product CodeNGX
Date Received2015-12-09
Model Number0517
Catalog Number0517-5000
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, H91 NHT7 EI H91 NHT7


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2015-12-09

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