FDA Adverse Event
Malfunction
Summary report: N
ALLEN STIRRUPS (SAM I)
MDR report key: 111777
·
Received August 8, 1997
Report
- Report Number
- 111777
- Event Type
- Malfunction
- Date Received
- August 8, 1997
- Date of Event
- August 5, 1997
- Report Date
- August 7, 1997
- Manufacturer
- ALLEN MEDICAL SYSTEMS
- Product Code
- EYD
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- FL, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
PT IN SURGERY. ALLEN STIRRUPS BEING UTILIZED. LEFT LEG FELL DOWN IN STIRRUP FOR NO REASON, WITH NO ONE TOUCHING STIRRUP OR PT, WHILE PT ANESTHETIZED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ALLEN STIRRUPS (SAM I) | PT LEG SUPPORT-OPERATING ROOM | EYD | ALLEN MEDICAL SYSTEMS | SAM I - 0017 | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 42 YR |