SLENDERTONE ABS MALE 392 0392-1000

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2016-01-21 for SLENDERTONE ABS MALE 392 0392-1000 manufactured by Bio-medical Research Ltd.

Event Text Entries

[36469537] The device was not returned for evaluation and without a serial number no review of the device history record could be completed. Consumer provided letter from his doctors stating he was suffering from diastasis recti abdominis but did not confirm this was caused by the slendertone device. Consumer advised he had purchased the product 9 years previous and had been using it for a long period of time. At this time, no link has been established between the adverse event and the use of the slendertone device. Upon retrospective review, this issue was determined to be reportable as an mdr.
Patient Sequence No: 1, Text Type: N, H10


[36469538] Consumer advised he is suffering from a lump poking through his ribs. He is a pe teacher and is unable to exercise his abdominals and this is affecting his job.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number8020867-2015-00019
MDR Report Key5382465
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2016-01-21
Date of Report2013-04-15
Date of Event2013-04-15
Date Mfgr Received2013-04-15
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 MALE
Generic NamePOWERED MUSCLLE STIMULATOR
Product CodeNGX
Date Received2016-01-21
Model Number392
Catalog Number0392-1000
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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