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

Model Number 392

Device Problem Insufficient Information (3190)

Patient Problem Hernia (2240)

Event Date 04/15/2013

Event Type  Injury  

Manufacturer Narrative

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.

Event Description

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.

• Brand Name: SLENDERTONE ABS MALE
• Type of Device: POWERED MUSCLLE 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: 5382465
• MDR Text Key: 36469537
• Report Number: 8020867-2015-00019
• Device Sequence Number: 1
• Product Code: NGX
• Combination Product (y/n): N
• Reporter Country Code: EI
• PMA/PMN Number: K070142
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/15/2013

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: 392
• Device Catalogue Number: 0392-1000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/15/2013
• Initial Date FDA Received: 01/21/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 58 YR