FDA Adverse Event
Other
Summary report: N
GUARDIAN
MDR report key: 320691
·
Received March 16, 2001
Report
- Report Number
- 2020334-2001-00007
- Event Type
- Other
- Date Received
- March 16, 2001
- Report Date
- March 16, 2001
- Manufacturer
- SUNRISE MEDICAL/PCP DIVISION
- Product Code
- ITJ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- PATIENT
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT THE USER LOST BALANCE WHILE USING THE WALKER. THE USER FELL ONTO THE WALKER BREAKING WRIST.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 11812 | GUARDIAN | WALKER | ITJ | SUNRISE MEDICAL/PCP DIVISION | 7990 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR | Other |