FDA Adverse Event
Other
Summary report: N
GUARDIAN WALKER
MDR report key: 385287
·
Received March 29, 2002
Report
- Report Number
- 2020334-2002-00003
- Event Type
- Other
- Date Received
- March 29, 2002
- Date of Event
- March 1, 2002
- Report Date
- March 29, 2002
- Manufacturer
- SUNRISE MEDICAL/PCP DIVISION
- Product Code
- ITJ
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT END USER WAS USING THE WALKER IN THEIR HOME, WHEN THE WALKER TURNED FURTHER THAN USER ANTICIPATED, ALLEGEDLY CAUSING THEM TO FALL. USER REQUIRED STITCHES TO THEIR HAND.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GUARDIAN WALKER | PATIENT WALKER | ITJ | SUNRISE MEDICAL/PCP DIVISION | 30755P | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 98 YR | Other |