FDA Adverse Event
Other
Summary report: N
GUARDIAN CANE
MDR report key: 312809
·
Received January 19, 2001
Report
- Report Number
- 2020334-2001-00002
- Event Type
- Other
- Date Received
- January 19, 2001
- Date of Event
- December 14, 2000
- Report Date
- January 19, 2001
- Manufacturer
- SUNRISE MEDICAL / PCP DIVISION
- Product Code
- IPS
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- PATIENT
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT THE END USER HAD JUST GOT UP FROM THE COUCH, HAD TAKEN A FEW STEPS WHEN THE CANE BROKE. THE USER FELL HITTING USER'S HEAD ON A DOOR. REQUIRED STITCHES TO USER'S HEAD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2664 | GUARDIAN CANE | CANE | IPS | SUNRISE MEDICAL / PCP DIVISION | 30340 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 72 YR | Other |