MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,foreign report with the FDA on 2016-01-21 for SLENDERTONE FACE 371 manufactured by Bio-medical Research Ltd.
[36465469]
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).
Patient Sequence No: 1, Text Type: N, H10
[36465470]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8020867-2015-00013 |
| MDR Report Key | 5382412 |
| Report Source | CONSUMER,FOREIGN |
| Date Received | 2016-01-21 |
| Date of Report | 2012-02-21 |
| Date of Event | 2011-12-01 |
| Date Mfgr Received | 2012-02-21 |
| Date Added to Maude | 2016-01-21 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. ANNE-MARIE KEENAN |
| Manufacturer Street | PARKMORE BUSINESS PARK, WEST |
| Manufacturer City | GALWAY, H91 NHT7 |
| Manufacturer Country | EI |
| Manufacturer Postal | H91 NHT7 |
| Manufacturer Phone | 91774316 |
| Manufacturer G1 | BIO-MEDICAL RESEARCH LTD |
| Manufacturer Street | PARKMORE BUSINESS PARK, WEST |
| Manufacturer City | GALWAY, H91 NHT7 |
| Manufacturer Country | EI |
| Manufacturer Postal Code | H91 NHT7 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SLENDERTONE FACE |
| Generic Name | FACIAL STIMULATOR |
| Product Code | NFO |
| Date Received | 2016-01-21 |
| Model Number | 371 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIO-MEDICAL RESEARCH LTD |
| Manufacturer Address | PARKMORE BUSINESS PARK, WEST GALWAY, H91 NHT7 EI H91 NHT7 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-01-21 |