FDA Adverse Event
Other
Summary report: N
GUARDIAN WALKER
MDR report key: 378258
·
Received February 22, 2002
Report
- Report Number
- 2020334-2002-00002
- Event Type
- Other
- Date Received
- February 22, 2002
- Report Date
- February 22, 2002
- Manufacturer
- SUNRISE MEDICAL, PCP DIVISION
- Product Code
- ITJ
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KY, US
- Reporter Occupation
- UNKNOWN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT THE USER OF THE WALKER FELL WHEN THE WALKER COLLAPSED, CAUSING UNSPECIFIED INJURIES. THE WALKER HAD BEEN IN USE SINCE 1997.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GUARDIAN WALKER | WALKER | ITJ | SUNRISE MEDICAL, PCP DIVISION | 30755P | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other |