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

Model Number 399

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Chest Pain (1776)

Event Date 04/11/2013

Event Type  Injury  

Manufacturer Narrative

Consumer did not provide a medical report.Evaluation of the device showed no issue with the device.Device history records showed no major issues within the batch.No link has been established at this time between the use of the device and the adverse event reported.Upon retrospective review, this issue was determined to be reportable as an mdr.

Event Description

Event was reported by consumers daughter on behalf of her mother.The consumer claimed after using the device 4 times, she suffered chest pains and was taken to hospital.At the hospital she was told of possible muscle and nerve damage.

• Brand Name: SLENDERTONE ABS
• Type of Device: POWERED MUSCLE STIMULATOR
• Manufacturer (Section D): BIO-MEDICAL RESEARCH LTD; parkmore business park west; galway; galway, H91-N HT7; EI H91-NHT7
• Manufacturer (Section G): BIO-MEDICAL RESEARCH LTD; parkmore business park west; galway; galway, H91-N HT7; EI H91-NHT7
• Manufacturer Contact: andrea small ; parkmore business park west; galway; galway, H91 N-HT7 ; EI H91 NHT7 ; 91774350
• MDR Report Key: 5382468
• MDR Text Key: 36470120
• Report Number: 8020867-2015-00020
• Device Sequence Number: 1
• Product Code: NGX
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K100320
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/17/2013

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: 399
• Device Catalogue Number: 0399-2052
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2013
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/17/2013
• Initial Date FDA Received: 01/21/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/07/2012
• 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): Other
• Patient Age: 61 YR