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 0515-2004 manufactured by Bio-medical Research Ltd..
[32975401]
The consumer did not wish to provide any further details. 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 slendertone device.
Patient Sequence No: 1, Text Type: N, H10
[32975402]
The consumer has reported abdominal cramps, diarrhoea, blood in stool and also vaginal bleeding with abdominal pain and contractions. The consumer has stated that it feels like muscles are contracting when the belt is not on. The consumer has not consulted a doctor.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8020867-2015-00006 |
| MDR Report Key | 5275567 |
| Report Source | CONSUMER |
| Date Received | 2015-12-08 |
| Date of Report | 2014-02-26 |
| Date of Event | 2014-01-01 |
| Date Mfgr Received | 2014-02-27 |
| Device Manufacturer Date | 2013-11-29 |
| 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 | 0515-2004 |
| 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 |