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

Model Number 372

Device Problem Insufficient Information (3190)

Patient Problem Retinal Detachment (2047)

Event Date 02/24/2014

Event Type  Injury  

Manufacturer Narrative

Consumer contacted call centre to report he suffered a detached retina after using the device.He stated he did not wish to pursue a medical complaint and was only highlighting the issue.Consumer left no name or contact details and did not wish to be contacted further.No medical report / evaluation was provided.Device was not returned for evaluation.Device history records could not be evaluated as no serial number was provided.A conversation was held between bmrs senior clinical scientist and a consultant ophthalmic surgeon in the galway clinic in relation to slendertone face device and other facial toning devices and the clinical possibility of inducing retinal detachment.The surgeon indicated to establish a direct casual link one would have to demonstrate a transient rise in pressure or tangential forces on the eyes during the device use.On reviewing this complaint, the surgeon referred to a condition known as entropion where the eyelid muscles become mal positioned and cause the eyelids to turn inwards causing redding and irritation of the eye.The surgeon believes retina detachment is usually accompanied by preceding trauma or an underlying condition.In some cases where a person has an underlying condition, it would be advisable to consult a qualified professional beforehand, however, he does not believe there is a direct link between the slendertone face device and this complaint.Upon retrospective review, this issue was determined to be reportable as an mdr.

Event Description

Consumer called the customer care team to say he was convinced he had a detached retina after using the slendertone face product.He used the unit 3-4 times and each time his eye became very red.He advised he did not want to pursue a medical complaint and did not leave his name and number as he did not wish to be contacted.He wanted to make the company aware of his condition.

• Brand Name: SLENDERTONE MALE FACE
• Type of Device: POWER 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: 5382478
• MDR Text Key: 36471316
• Report Number: 8020867-2015-00024
• 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: 02/24/2014

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: 372
• Device Catalogue Number: 0372-2050
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/24/2014
• 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: 55 YR