MAUDE Adverse Event Report: BIO-MEDICAL RESEARCH LTD. SLENDERTONE ABS S7; POWERED MUSCLE STIMULATOR

Model Number 398

Device Problem Insufficient Information (3190)

Patient Problems Chest Pain (1776); Dyspnea (1816); Tachycardia (2095); Palpitations (2467)

Event Date 06/07/2015

Event Type  Injury  

Manufacturer Narrative

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.

Event Description

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.

• Brand Name: SLENDERTONE ABS S7
• Type of Device: POWERED MUSCLE STIMULATOR
• Manufacturer (Section D): BIO-MEDICAL RESEARCH LTD.; parkmore business park; galway, H91 N HT7; EI H91 NHT7
• Manufacturer (Section G): BIO-MEDICAL RESEARCH LTD; parkmore business park west; galway, H91 N HT7; EI H91 NHT7
• Manufacturer Contact: anne-marie keenan ; parkmore business park; galway, H91 N-HT7 ; EI H91 NHT7 ; 91 774316
• MDR Report Key: 5382408
• MDR Text Key: 36468291
• Report Number: 8020867-2015-00029
• Device Sequence Number: 1
• Product Code: NGX
• Combination Product (y/n): N
• Reporter Country Code: EI
• PMA/PMN Number: K100320
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 11/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 398
• Device Catalogue Number: 0398-2052
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/10/2015
• Initial Date FDA Received: 01/21/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 30 YR