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 Problem Retinal Detachment (2047)

Event Date 12/01/2011

Event Type  Injury  

Manufacturer Narrative

The root cause of the complaint is inconclusive.A conversation was held between the senior clinical scientist of bio-medical research ltd.And a consultant ophthalmic surgeon in relation to slendertone face device and other facial toning devices and the clinical possibility of inducing retinal detachment.The surgeon indicated that 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 review of 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 is advisable to consult a qualified professional beforehand, however, he does not believe there is a direct link between use of the slendertone face device and this complaint.The device itself was returned to bio-medical research ltd.For evaluation and no failure was detected.This complaint has been reported as part of a retrospective review of complaints representing events that are mdr reportable.The device history record was reviewed and the device was confirmed to have met it's manufacturing specifications.(b)(4).

Event Description

Bio-medical research ltd.Was notified on the february 21, 2012, via email, by it's call centre of a complaint regarding the slendertone face.A (b)(6) year old female customer had purchased the device in march 2011 and had completed 50-60 sessions in total (approx.2-3 times per week).The patient has reported that following pain in her eyes, she had visited a doctor and was subsequently diagnosed with retinal detachment in her right eye.The doctor advised her not to use device again and laser photocoagulation treatment was recommended.

• 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: 5382412
• MDR Text Key: 36465469
• Report Number: 8020867-2015-00013
• 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: 02/21/2012

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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/21/2012
• Was Device Evaluated by Manufacturer?: Yes
• 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): Required Intervention
• Patient Age: 59 YR