FDA Adverse Event
Malfunction
Summary report: N
A13309A
MDR report key: 192662
·
Received October 16, 1998
Report
- Report Number
- 1418964-1998-00003
- Event Type
- Malfunction
- Date Received
- October 16, 1998
- Date of Event
- October 6, 1998
- Report Date
- October 15, 1998
- Manufacturer
- GENDEX-DEL MEDICAL IMAGING CORP.
- Product Code
- IYB
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OK, US
- Reporter Occupation
- SERVICE PERSONNEL
Narratives
Description of Event or Problem · 1
TUBESTAND BECAME DISENGAGED FROM FLOOR AND CEILING RAILS. TUBESTAND FELL TO ASSISTING THE PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | A13309A | TUBESTAND | IYB | GENDEX-DEL MEDICAL IMAGING CORP. | A13309A | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * | Required Intervention |