MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-03-09 for FITBIT ARIA BODY FAT SCALE manufactured by .
[3379323]
The body fat scale measured body fat by passing a current through foot. The current was "shocking" when our kids would step on it. Since it is kept in bathroom, it is hard to tell everyone not to use it. Their manual does not describe that it passes a current through the body.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5029346 |
| MDR Report Key | 3006465 |
| Date Received | 2013-03-09 |
| Date of Report | 2013-03-09 |
| Date of Event | 2013-02-16 |
| Date Added to Maude | 2013-03-18 |
| 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 | 0 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FITBIT ARIA BODY FAT SCALE |
| Generic Name | FITBIT IT ARIA |
| Product Code | FRW |
| Date Received | 2013-03-09 |
| Model Number | ARIA |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening | 2013-03-09 |