MAUDE Adverse Event Report: BIO-MEDICAL RESEARCH LTD SLENDERTONE FACE; FACIAL STIMULATOR

Model Number 371

Device Problem Insufficient Information (3190)

Patient Problem Sensitivity of Teeth (2427)

Event Date 03/19/2014

Event Type  Injury  

Manufacturer Narrative

Information was provided to (b)(4) via social media and no customer contact information was provided.The device was not returned for testing and the root cause could not be established.This complaint has been reported as part of a retrospective review of complaints representing events that are mdr reportable.

Event Description

(b)(4) was notified on (b)(6) 2014, via email from a trade customer, of a complaint through it's social media.A customer had reported that on use of the slendertone face for 2 -3 weeks, he/she had experienced a broken porcelain crown and a loose bridge.No customer contact details were provided to (b)(4) and no further medical information was provided.

• Brand Name: SLENDERTONE FACE
• Type of Device: FACIAL 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: 5382427
• MDR Text Key: 36464925
• Report Number: 8020867-2015-00025
• Device Sequence Number: 1
• Product Code: NFO
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K103031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/19/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/21/2016
• 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?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/19/2014
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other