MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-01-02 for FITBIT CHARGE 2 manufactured by Fitbit.
[96335546]
Received fitbit charge 2 device as a free gift from my employer to record my physical activity and began using it on (b)(6) 2017. After a week or so of use i started having dizzy spells. At one point while driving, i had to pull off the road at one point because i could no longer see the road. Coincidentally, i had my yearly physical on (b)(6) 2017. Blood tests revealed hypothyroidism: tsh = 9. 96, free t4 = 0. 8, and t4 total= 4. 7. I had a problem with my thyroid in the past, however, i've been off medication for over 2 years. I stopped using the device (b)(6) 2017.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5074387 |
| MDR Report Key | 7159835 |
| Date Received | 2018-01-02 |
| Date of Report | 2017-12-29 |
| Date of Event | 2017-10-24 |
| Date Added to Maude | 2018-01-03 |
| 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 | 0 |
| Brand Name | FITBIT CHARGE 2 |
| Generic Name | ANALYZER, BODY COMPOSITION |
| Product Code | MNW |
| Date Received | 2018-01-02 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | FITBIT |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2018-01-02 |