MAUDE Adverse Event Report: BIO-MEDICAL RESEARCH LTD SLENDETONE FACE; POWERED MUSCLE STIMULATOR

Model Number 371

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pain (1994)

Event Date 10/15/2012

Event Type  Injury  

Manufacturer Narrative

Device was tested and no fault was found.Consumers oral surgeon could did not confirm the device as the cause of her injury.(b)(6) md and bmrs technical director reviewed the evidence and concluded the device was tested and is working normally and that there was no causal link between the use of the slendertone device and the reported event.Upon retrospective review, this issue was determined to be reportable as an mdr.

Event Description

Consumer bought her face unit in (b)(6) 2011.She reported in (b)(6) 2012 the intensity of her face unit was very weak and she was provided with a replacement.She later reported the intensity in the replacement unit was also weak and requested a refund.While the returned unit was being tested, the consumer contacted the call centre to state she wanted a refund and not a replacement.She also stated she had an ache in her jaw and it was painful to eat.The consumer was refunded.She later contacted bmr again to say she had been unable to eat properly and her orthopedic surgeon could find a reproducible click coming from the right temporo-mandibular joint.

• Brand Name: SLENDETONE FACE
• 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: 5403568
• MDR Text Key: 37269548
• Report Number: 8020867-2015-00016
• Device Sequence Number: 1
• Product Code: NGX
• Combination Product (y/n): N
• Reporter Country Code: EI
• PMA/PMN Number: K103031
• 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: 10/22/2012

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: 371
• Device Catalogue Number: 0371-2054
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2012
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/22/2012
• Initial Date FDA Received: 02/02/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/12/2012
• 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