FDA Adverse Event
Injury
Summary report: N
G.E. MEDICAL
MDR report key: 365661
·
Received December 10, 2001
Report
- Report Number
- 365661
- Event Type
- Injury
- Date Received
- December 10, 2001
- Date of Event
- June 28, 2001
- Report Date
- December 7, 2001
- Manufacturer
- G.E. MEDICAL SYSTEMS
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- NY, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
PT WAS TO HAVE ORIF OF LEFT MIDDLE METACARPAL. UNABLE TO COMPLETE PROCEDURE DUE TO FAILURE OF C-ARM. CAST WAS RE-APPLIED. NO PERMANENT HARM TO PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 55449 | G.E. MEDICAL | C-ARM | JAA | G.E. MEDICAL SYSTEMS | 8284906035 | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 15 YR | Required Intervention |