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

Model Number 517

Device Problem Insufficient Information (3190)

Patient Problem Hematuria (2558)

Event Date 01/19/2015

Event Type  Injury  

Manufacturer Narrative

The root cause was not established as the customer did not return the device after 5 contact attempts by manufacturer.Device was not returned for evaluation and no medical report was made available for review.

Event Description

Customer reported that she suffered uterine bleeding after using the ultra belt twice (over a period of two days), she then stopped using it (for one day) and the bleeding stopped.She then used it again and on the same day the bleeding started again.The patient then consulted her gynaecologist who examined her and told her there was no underlying reason for the bleeding (she could find nothing wrong) and she was advised to stop using the belt.Since she stopped using the belt there has been no bleeding.

• Brand Name: SLENDERTONE ULTRA
• 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: 5276509
• MDR Text Key: 32976055
• Report Number: 8020867-2015-00004
• Device Sequence Number: 1
• Product Code: NGX
• Combination Product (y/n): N
• Reporter Country Code: EI
• PMA/PMN Number: K100556
• 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: 11/24/2015

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: 517
• Device Catalogue Number: 0517-5006
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/19/2015
• Initial Date FDA Received: 12/09/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/29/2014
• 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