FDA Adverse Event
Malfunction
Summary report: N
ALLEN
MDR report key: 18038393
·
Received October 31, 2023
Report
- Report Number
- 18038393
- Event Type
- Malfunction
- Date Received
- October 31, 2023
- Date of Event
- April 3, 2023
- Report Date
- September 15, 2023
- Manufacturer
- ALLEN MEDICAL SYSTEMS, INC.
- Product Code
- FWZ
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- AZ
- Reporter Occupation
- RISK MANAGER
- Health Professional
- N
Narratives
Description of Event or Problem · 0
PATIENT ON OPERATING ROOM TABLE IN STIRRUPS, SLID DOWN DURING PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2124872 | ALLEN | OPERATING ROOM ACCESSORIES TABLE TRAY | FWZ | ALLEN MEDICAL SYSTEMS, INC. | 102001 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 27010 DA | Female |