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

Model Number 371

Device Problem Insufficient Information (3190)

Patient Problem Rash (2033)

Event Date 01/08/2013

Event Type  Injury  

Manufacturer Narrative

Consumer reported a rash after using her face unit for 3 months.She suffers from allergies and cannot use scented products or perfumes on her skin.She assumes she may be allergic to the pads.The device was returned to the place of purchase and the serial number was not available, therefore no evaluation of the device or it device history record could be completed.Upon retrospective review, this issue was determined to be reportable as an mdr.Device was returned to place of purchase.

Event Description

Consumer only used the device once or twice a week due to known history of allergies.After 3 months of use she reported rash burns on her skin.She used hydrocortisone cream and eumovate ointment prescribed by her doctor on previous occasions for other events not related to the use of slendertone devices.She did not see a doctor for this event.

• Brand Name: SLENDERTONE 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: 5382442
• MDR Text Key: 36468083
• Report Number: 8020867-2015-00017
• 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: 01/15/2013

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?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/21/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Age: 62 YR