SLENDERTONE FLEX PRO 515 0515-5054

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 2015-12-08 for SLENDERTONE FLEX PRO 515 0515-5054 manufactured by Bio-medical Research Ltd..

Event Text Entries

[32975988] Full investigation could be completed as device was not returned for evaluation and no medical report was made available.
Patient Sequence No: 1, Text Type: N, H10


[32975989] The consumer has reported burns on her back and stomach.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number8020867-2015-00003
MDR Report Key5275570
Report SourceCONSUMER
Date Received2015-12-08
Date of Report2015-04-24
Date of Event2015-01-01
Date Mfgr Received2015-04-24
Device Manufacturer Date2015-01-02
Date Added to Maude2015-12-08
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 FLEX PRO
Generic NamePOWERED MUSCLE STIMULATOR
Product CodeNGX
Date Received2015-12-08
Model Number515
Catalog Number0515-5054
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 2015-12-08

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