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

Model Number 371

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

Patient Problems Pain (1994); Rash (2033); Skin Inflammation (2443)

Event Date 01/04/2014

Event Type  Injury  

Manufacturer Narrative

No medical reports were provided to bio-medical research ltd as part of the investigation.The device was returned to bio-medical research ltd and testing performed showed the device performed per it's specification.Adverse reactions of skin irritation and burns beneath the electrodes have been reported with the use of powered muscle stimulators.This known risk has been documented in the risk assessment and also user instructions for use of the device - 'a small number of isolated skin reactions have been reported by people using muscle stimulation devices, including allergies, a prolonged reddening of the skin and acne'.The date of event provided is best estimate based on purchase date and date of event.This complaint has been reported as part of a retrospective review of complaints representing events that are mdr reportable.

Event Description

Bio-medical research ltd.Was notified on (b)(6) 2014 via email by it's call centre that they had received a complaint regarding the slendertone face.The female customer has purchased the device on (b)(6) 2014 and had used it three times for approximately 10 minutes each.The customer reported that she received pains in her throat and nose area, along with a burning sensation.The customer reported that her face became red and inflamed.She visited her doctor and was prescribed with anti inflammatory medication.She stopped using the product for three weeks and tried it again on (b)(6) and 22 for 10 minutes each time.She again started to experience a burning sensation in the throat and nose area.She reported that she stopped using the device due to pain.

• 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: 5382432
• MDR Text Key: 36468427
• Report Number: 8020867-2015-00026
• Device Sequence Number: 1
• Product Code: NFO
• 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: 04/23/2014

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/23/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/24/2013
• 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