FDA Adverse Event
Other
Summary report: N
GUARDIAN WALKER
MDR report key: 321116
·
Received March 19, 2001
Report
- Report Number
- 2020334-2001-00008
- Event Type
- Other
- Date Received
- March 19, 2001
- Report Date
- March 19, 2001
- Manufacturer
- SUNRISE MEDICAL/PCP DIVISION
- Product Code
- ITJ
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT THE END USER FELL OVER AND ONTO THE WALKER. USER SUFFERED WITH TWO CRACKED RIBS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 12098 | GUARDIAN WALKER | PATIENT WALKER | ITJ | SUNRISE MEDICAL/PCP DIVISION | 30755P | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 56 YR | Other |