FDA Adverse Event
Injury
Summary report: N
C-MILL
MDR report key: 13319044
·
Received January 21, 2022
Report
- Report Number
- 3006750942-2021-00001
- Event Type
- Injury
- Date Received
- January 21, 2022
- Date of Event
- January 15, 2021
- Report Date
- December 23, 2021
- Manufacturer
- MOTEK MEDICAL B.V.
- Product Code
- IOL
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
AN EMPLOYEE BROKE HER FINGER WHILE ATTEMPTING TO ADJUST THE HANDRAILS. IT WAS THE OPERATOR/ THERAPIST, NOT THE PATIENT, WHO WAS INJURED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 686666 | C-MILL | POWERED TREATMILL | IOL | MOTEK MEDICAL B.V. | VR+ |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 28 YR | Unknown | Required Intervention |