MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-11-05 for BODYMEDIA CORE manufactured by Bodymedia.
[15018951]
I am a user of a device called body media core. It monitors body activity by reading 5000 data points per minute (seller claim). I've used the device for more than 1 year and have noticed that it burns and discolors the skin. The seller recommends using it in 1 location on the left arm for 23 hours per day. To do so will lead to injury. I have adapter by moving the device to at least 4 locations and not keeping it in any one of those locations for more than 12 hours. My skin is irritated and discolored nonetheless. I have notified the seller.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5032610 |
| MDR Report Key | 3458650 |
| Date Received | 2013-11-05 |
| Date of Report | 2013-10-26 |
| Date Added to Maude | 2013-11-12 |
| 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 | PATIENT |
| 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 | BODYMEDIA CORE |
| Generic Name | BODY ACTIVITY MONITOR |
| Product Code | IKK |
| Date Received | 2013-11-05 |
| Operator | LAY USER/PATIENT |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BODYMEDIA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-11-05 |