SLENDERTONE ABS 398 0398-2052

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 ABS 398 0398-2052 manufactured by Bio-medical Research Ltd.

Event Text Entries

[36526168] Returned device passed testing as per test requirements. Review of device history records at supplier site showed no major issues in the manufacturing process for that batch. No medical report was supplied by the consumer. Instruction manual dos and donts section indicates 'a small number of isolated skin reactions have been reported by people using muscle stimulation devices.... '. Based on the limited information to hand, it appears the consumer may have suffered a known adverse reaction. Upon retrospective review, this issue was determined to be reportable as an mdr.
Patient Sequence No: 1, Text Type: N, H10


[36526169] Consumer used the abs belt 3 times and noticed itchy spots under the pads. After 3 weeks the spots turned brown and began to go away. Her doctor prescribed aqueous cream and ointment which did not help and so then prescribed steroids, antibiotic and piriton.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number8020867-2015-00018
MDR Report Key5383256
Report SourceCONSUMER,FOREIGN
Date Received2016-01-21
Date of Report2013-02-25
Date of Event2013-01-24
Date Mfgr Received2013-02-25
Device Manufacturer Date2012-09-21
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 ABS
Generic NamePOWERED MUSCLE STIMULATOR
Product CodeNGX
Date Received2016-01-21
Returned To Mfg2013-05-01
Model Number398
Catalog Number0398-2052
OperatorLAY USER/PATIENT
Device AvailabilityR
Device Eval'ed by MfgrY
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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