SLENDERTONE ABS S7 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 S7 398 0398-2052 manufactured by Bio-medical Research Ltd..

Event Text Entries

[36468291] The device (serial number (b)(4)) was tested and found to be operating within expected output parameter ranges. The device history record was reviewed and the device has been confirmed to have met it's specifications. On review of the medical report supplied to the manufacturer, pre-existing medical conditions of bulimia and stress factors were detailed. At this time, no link has been established between the adverse event and the use of the slendertone device.
Patient Sequence No: 1, Text Type: N, H10


[36468292] Bio-medical research ltd. Was notified on june 10, 2015 via email by it's call centre that they had received a complaint regarding the slendertone abs (part number 0390-2008). The female customer had purchased the device on (b)(6) 2015. The customer had reported on using the device 4 times, she encountered issues with her heartbeat (rapid heartbeat). She was in hospital for 3 days and received a full check-up. During her hospitalization, her condition was reviewed and the patient was diagnosed as having dyspnea with heart palpitations and chest pains. The patient recovered but was advised against future use of the device.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number8020867-2015-00029
MDR Report Key5382408
Report SourceCONSUMER,FOREIGN
Date Received2016-01-21
Date of Report2015-11-23
Date of Event2015-06-07
Date Mfgr Received2015-06-10
Device Manufacturer Date2015-01-01
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
Reporter OccupationPATIENT
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMS. ANNE-MARIE KEENAN
Manufacturer StreetPARKMORE BUSINESS PARK
Manufacturer CityGALWAY, H91 NHT7
Manufacturer CountryEI
Manufacturer PostalH91 NHT7
Manufacturer Phone91 774316
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 ABS S7
Generic NamePOWERED MUSCLE STIMULATOR
Product CodeNGX
Date Received2016-01-21
Returned To Mfg2015-06-22
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 GALWAY, H91 NHT7 EI H91 NHT7


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization 2016-01-21

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