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 0371-2054 manufactured by Bio-medical Research Ltd.
[36468083]
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.
Patient Sequence No: 1, Text Type: N, H10
[36468084]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8020867-2015-00017 |
| MDR Report Key | 5382442 |
| Report Source | CONSUMER,FOREIGN |
| Date Received | 2016-01-21 |
| Date of Report | 2013-01-15 |
| Date of Event | 2013-01-08 |
| 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 FACE |
| Generic Name | POWERED MUSCLE STIMULATOR |
| Product Code | NGX |
| Date Received | 2016-01-21 |
| Model Number | 371 |
| Catalog Number | 0371-2054 |
| 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 |