MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-12-08 for SLENDERTONE FLEX PRO 515 0515-5054 manufactured by Bio-medical Research Ltd..
[32986192]
The consumer did not wish to provide any further details after the initial report. The device was not returned for evaluation and no medical report was provided as part of the investigation. At this time, no link has been established between the adverse event and the use of the slender tone device.
Patient Sequence No: 1, Text Type: N, H10
[32986193]
Consumer reported a shocking sensation during device use and also reported feeling a burning sensation. Consumer reported a half-inch burn on her skin.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8020867-2015-00008 |
| MDR Report Key | 5275557 |
| Date Received | 2015-12-08 |
| Date of Report | 2014-02-25 |
| Date of Event | 2014-02-25 |
| Date Mfgr Received | 2014-02-25 |
| Date Added to Maude | 2015-12-08 |
| 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 | 0 |
| Brand Name | SLENDERTONE FLEX PRO |
| Generic Name | POWERED MUSCLE STIMULATOR |
| Product Code | NGX |
| Date Received | 2015-12-08 |
| Model Number | 515 |
| Catalog Number | 0515-5054 |
| 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, H91 NHT7 EI H91 NHT7 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-12-08 |