MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-04-09 for SLENDERTONE manufactured by .
[42629033]
Diagnosed with the sudden onset of diverticulosis covering a large area of the colon during annual check up. This onset coincided with frequent (five to six days a week) use of ems apparatus (slendertone) over the previous 6 months in the abdominal area. There must be a strong probability that the severe contractions induced by this kind of apparatus might well cause the internal herniations that are diverticula.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5061649 |
| MDR Report Key | 5573397 |
| Date Received | 2016-04-09 |
| Date of Report | 2016-04-09 |
| Date Added to Maude | 2016-04-13 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SLENDERTONE |
| Generic Name | SLENDERTONE |
| Product Code | NGX |
| Date Received | 2016-04-09 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2016-04-09 |