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

Model Number 0517

Device Problem Insufficient Information (3190)

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Date 08/29/2014

Event Type  Injury  

Manufacturer Narrative

No action taken as customer did not return product for investigation and on 11.11.14 the customer requested that we close out the complaint.Note no medical report or other evidence was supplied by the customer.The slendertone ultra ifu provides the following information contact slendertone if: you experience any irritation, skin reaction, hypersensitivity, or other adverse reaction.

Event Description

The customer experienced discomfort and sores/puss from sores on skin.The customer went to doctor and was told that he was allergic to gel pads.The customer has not used the belt since.

• 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: 5276521
• MDR Text Key: 32975639
• Report Number: 8020867-2015-00005
• Device Sequence Number: 1
• Product Code: NGX
• Combination Product (y/n): N
• Reporter Country Code: EI
• PMA/PMN Number: K100320
• 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: 08/29/2014

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: 0517
• Device Catalogue Number: 0517-5000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/29/2014
• Initial Date FDA Received: 12/09/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/19/2013
• 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