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 MALE FACE 372 0372-2050 manufactured by Bio-medical Research Ltd.
[36471316]
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.
Patient Sequence No: 1, Text Type: N, H10
[36471317]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8020867-2015-00024 |
| MDR Report Key | 5382478 |
| Report Source | CONSUMER,FOREIGN |
| Date Received | 2016-01-21 |
| Date of Report | 2014-02-24 |
| Date of Event | 2014-02-24 |
| Date Mfgr Received | 2014-02-24 |
| 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 ANDREA SMALL |
| Manufacturer Street | PARKMORE BUSINESS PARK WEST GALWAY |
| Manufacturer City | GALWAY, H91 NHT7 |
| Manufacturer Country | EI |
| Manufacturer Postal | H91 NHT7 |
| Manufacturer Phone | 91774350 |
| Manufacturer G1 | BIO-MEDICAL RESEARCH LTD |
| Manufacturer Street | PARKMORE BUSINESS PARK WEST GALWAY |
| 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 MALE FACE |
| Generic Name | POWER MUSCLE STIMULATOR |
| Product Code | NGX |
| Date Received | 2016-01-21 |
| Model Number | 372 |
| Catalog Number | 0372-2050 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIO-MEDICAL RESEARCH LTD |
| Manufacturer Address | PARKMORE BUSINESS PARK WEST GALWAY GALWAY, H91-NHT7 EI H91-NHT7 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-01-21 |