FDA Adverse Event
Other
Summary report: N
GUARDIAN QUADCANE
MDR report key: 317850
·
Received February 28, 2001
Report
- Report Number
- 2020334-2001-00005
- Event Type
- Other
- Date Received
- February 28, 2001
- Report Date
- February 28, 2001
- Manufacturer
- SUNRISE MEDICAL PCP DIV
- Product Code
- IPS
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PATIENT
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT THE END USER WAS APPROACHING THE COMMODE, WHEN ALLEGEDLY THE CANE BROKE, WHICH WAS ASSISTING USER TO REACH THE COMMODE. THE USER FELL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 8434 | GUARDIAN QUADCANE | CANE | IPS | SUNRISE MEDICAL PCP DIV | 5345S | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 86 YR | Other |