FDA Adverse Event
Injury
Summary report: N
ECOLAB
MDR report key: 9714313
·
Received February 14, 2020
Report
- Report Number
- 1043582-2020-00001
- Event Type
- Injury
- Date Received
- February 14, 2020
- Date of Event
- January 26, 2020
- Report Date
- January 30, 2020
- Manufacturer
- MICROTEK MEDICAL INC.
- Product Code
- KME
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- 501
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT A PATENT FELL OUT OF THE ARM BOARD COVER AND FRACTURED THEIR RIGHT RADIUS AS A RESULT OF THE FALL. MEDICAL INTERVENTION WAS REQUIRED AND THE ARM WAS PLACED IN A CAST TO PREVENT PERMANENT DAMAGE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 177885 | ECOLAB | CLEANOP INFECTION CONTROL SYSTEM | KME | MICROTEK MEDICAL INC. | RWJUH-NB-04D |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |