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

Model Number 515

Device Problem Insufficient Information (3190)

Patient Problems Abdominal Pain (1685); Diarrhea (1811); Abdominal Cramps (2543); Intermenstrual Bleeding (2665)

Event Date 01/01/2014

Event Type  Injury  

Manufacturer Narrative

The consumer did not wish to provide any further details.The device was not returned for evaluation and no medical report was provided as part of the investigation.At this time, no link has been established between the adverse event and the use of the slendertone device.

Event Description

The consumer has reported abdominal cramps, diarrhoea, blood in stool and also vaginal bleeding with abdominal pain and contractions.The consumer has stated that it feels like muscles are contracting when the belt is not on.The consumer has not consulted a doctor.

• Brand Name: SLENDERTONE FLEX PRO
• Type of Device: POWERED MUSCLE STIMULATOR
• Manufacturer (Section D): BIO-MEDICAL RESEARCH LTD.; parkmore business park, west; 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, west; galway, H91 N-HT7 ; EI H91 NHT7 ; 91774316
• MDR Report Key: 5275567
• MDR Text Key: 32975401
• Report Number: 8020867-2015-00006
• Device Sequence Number: 1
• Product Code: NGX
• Combination Product (y/n): N
• Reporter Country Code: EI
• PMA/PMN Number: K030708
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/26/2014

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: 515
• Device Catalogue Number: 0515-2004
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/27/2014
• Initial Date FDA Received: 12/08/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/29/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other