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

Model Number 392

Device Problem Insufficient Information (3190)

Patient Problem Hernia (2240)

Event Date 04/01/2013

Event Type  Injury  

Manufacturer Narrative

Consumer reported he developed an umbilical hernia after using the slendertone device.He informed bmr that his doctor advised it may have been due to the use of the device.No medical report was provided by the consumer and the device was not returned for testing despite several attempts by bmr to have the device returned, therefore no root cause could be established.Bmrs (b)(4) advised he believes the user may have an underlying hernia or weakness with the abdominal wall prior to use.At this time no direct link between the use of the device and the symptoms reported could be established.Upon retrospective review, this issue was determined to be reportable as an mdr.

Event Description

Consumer reported he developed an umbilical hernia after using the device over several months.Consumer reported that after consulting his doctor, the doctor advised it may be due to the slendertone device.

• Brand Name: SLENDERTONE ABS MALE
• 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: 5382470
• MDR Text Key: 36470004
• Report Number: 8020867-2015-00021
• Device Sequence Number: 1
• Product Code: NGX
• Combination Product (y/n): N
• Reporter Country Code: HK
• PMA/PMN Number: K070142
• 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: 11/01/2013

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: 0392-2402
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/01/2013
• 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