FDA Adverse Event
Other
Summary report: N
HOMEDICS
MDR report key: 883061
·
Received July 19, 2007
Report
- Report Number
- 9680548-2007-00002
- Event Type
- Other
- Date Received
- July 19, 2007
- Date of Event
- June 13, 2007
- Report Date
- July 4, 2007
- Manufacturer
- ROSSMAX INTERNATIONAL LTD.
- Product Code
- DXN
- PMA / PMN Number
- K013539
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MT, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
NO RETURNED UNIT FOR EVALUATION.
Description of Event or Problem · 1
ACCORDING TO HOMEDICS, INC. MDR NO. 1832894-2007-00062 STATING, "CUSTOMER WAS TAKING MEDICINE THAT WARNS IT CAN RAISE BP, USED HOMEDICS BP UNIT BPA-250WGN IN 2007. HE CALLED THE PARAMEDICS BECAUSE HE THOUGHT HE WAS HAVING A HEART ATTACK, PARAMEDICS ARRIVED AND CUSTOMER WAS OKAY ONLY SCARED."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HOMEDICS | BLOOD PRESSURE MONITOR | DXN | ROSSMAX INTERNATIONAL LTD. | BPA-250WGN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | YR |