MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-02-03 for FITBIT CHARGE HR manufactured by Fitbit.
[37735955]
I purchased a fitbit hr specifically for the heart rate monitor. It inflamed my carpal tunnel syndrome and left a first degree burn on my wrist. The customer service rep told me to turn off the heart rate monitor, and i told her i'd rather return it. So she told me to try it on my ankle. It also caused pain inside my angle joint, left a painful second degree burn with a blister,a nd caused a painful cut where the latch dug into my skin overnight. I was promised a return authorization, but it never came. Also, the light up display would turn itself on frequently, waking me at night, and causing serious issues with my sleep disorders. The customer service rep said she fixed the setting so it wouldn't do that, but the fix only lasted one night.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5060041 |
| MDR Report Key | 5416678 |
| Date Received | 2016-02-03 |
| Date of Report | 2016-02-03 |
| Date of Event | 2016-01-08 |
| Date Added to Maude | 2016-02-08 |
| 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 HR |
| Generic Name | FITBIT CHARGE HR |
| Product Code | MNW |
| Date Received | 2016-02-03 |
| Model Number | CHARGE HR |
| Operator | LAY USER/PATIENT |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | FITBIT |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-02-03 |