FDA Adverse Event
Malfunction
Summary report: N
EASYTOUCH
MDR report key: 7661173
·
Received July 3, 2018
Report
- Report Number
- 3005798905-2018-00671
- Event Type
- Malfunction
- Date Received
- July 3, 2018
- Report Date
- July 3, 2018
- Manufacturer
- MHC MEDICAL PRODCUTS, LLC.
- Product Code
- NBW
- PMA / PMN Number
- K073492
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
EMAIL MESSAGES: A CUSTOMER RETURNED HIS GNP EASY TOUCH SYSTEM BECAUSE IT QUIT WORKING AFTER A WEEK. IT LOOKS AS IF THE BATTERY CORRODED, HE PUT A NEW BATTERY IN; IT STILL DOES NOT WORK.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 502346 | EASYTOUCH | BLOOD PRESSURE MONITOR | NBW | MHC MEDICAL PRODCUTS, LLC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |