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.
[36468427]
No medical reports were provided to bio-medical research ltd as part of the investigation. The device was returned to bio-medical research ltd and testing performed showed the device performed per it's specification. Adverse reactions of skin irritation and burns beneath the electrodes have been reported with the use of powered muscle stimulators. This known risk has been documented in the risk assessment and also user instructions for use of the device - 'a small number of isolated skin reactions have been reported by people using muscle stimulation devices, including allergies, a prolonged reddening of the skin and acne'. The date of event provided is best estimate based on purchase date and date of event. This complaint has been reported as part of a retrospective review of complaints representing events that are mdr reportable.
Patient Sequence No: 1, Text Type: N, H10
[36468429]
Bio-medical research ltd. Was notified on (b)(6) 2014 via email by it's call centre that they had received a complaint regarding the slendertone face. The female customer has purchased the device on (b)(6) 2014 and had used it three times for approximately 10 minutes each. The customer reported that she received pains in her throat and nose area, along with a burning sensation. The customer reported that her face became red and inflamed. She visited her doctor and was prescribed with anti inflammatory medication. She stopped using the product for three weeks and tried it again on (b)(6) and 22 for 10 minutes each time. She again started to experience a burning sensation in the throat and nose area. She reported that she stopped using the device due to pain.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8020867-2015-00026 |
| MDR Report Key | 5382432 |
| Report Source | CONSUMER,FOREIGN |
| Date Received | 2016-01-21 |
| Date of Report | 2014-04-23 |
| Date of Event | 2014-01-04 |
| Date Mfgr Received | 2014-04-23 |
| Device Manufacturer Date | 2013-05-24 |
| 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. 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 |
| Returned To Mfg | 2014-05-15 |
| Model Number | 371 |
| Catalog Number | 0371-2054 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| 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. Other | 2016-01-21 |