MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,foreign report with the FDA on 2016-02-02 for SLENDETONE FACE 371 0371-2054 manufactured by Bio-medical Research Ltd.
[37269548]
Device was tested and no fault was found. Consumers oral surgeon could did not confirm the device as the cause of her injury. (b)(6) md and bmrs technical director reviewed the evidence and concluded the device was tested and is working normally and that there was no causal link between the use of the slendertone device and the reported event. Upon retrospective review, this issue was determined to be reportable as an mdr
Patient Sequence No: 1, Text Type: N, H10
[37269549]
Consumer bought her face unit in (b)(6) 2011. She reported in (b)(6) 2012 the intensity of her face unit was very weak and she was provided with a replacement. She later reported the intensity in the replacement unit was also weak and requested a refund. While the returned unit was being tested, the consumer contacted the call centre to state she wanted a refund and not a replacement. She also stated she had an ache in her jaw and it was painful to eat. The consumer was refunded. She later contacted bmr again to say she had been unable to eat properly and her orthopedic surgeon could find a reproducible click coming from the right temporo-mandibular joint.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8020867-2015-00016 |
| MDR Report Key | 5403568 |
| Report Source | CONSUMER,FOREIGN |
| Date Received | 2016-02-02 |
| Date of Report | 2012-10-22 |
| Date of Event | 2012-10-15 |
| Date Mfgr Received | 2012-10-22 |
| Device Manufacturer Date | 2012-06-12 |
| Date Added to Maude | 2016-02-02 |
| 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 | SLENDETONE FACE |
| Generic Name | POWERED MUSCLE STIMULATOR |
| Product Code | NGX |
| Date Received | 2016-02-02 |
| Returned To Mfg | 2012-10-24 |
| 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 GALWAY, H91-NHT7 EI H91-NHT7 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-02-02 |