MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2015-12-08 for SLENDERTONE FLEX PRO 515 0515-5054 manufactured by Bio-medical Research Ltd..
[32975988]
Full investigation could be completed as device was not returned for evaluation and no medical report was made available.
Patient Sequence No: 1, Text Type: N, H10
[32975989]
The consumer has reported burns on her back and stomach.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8020867-2015-00003 |
| MDR Report Key | 5275570 |
| Report Source | CONSUMER |
| Date Received | 2015-12-08 |
| Date of Report | 2015-04-24 |
| Date of Event | 2015-01-01 |
| Date Mfgr Received | 2015-04-24 |
| Device Manufacturer Date | 2015-01-02 |
| 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 | 3 |
| 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 |