FDA Adverse Event
Injury
Summary report: N
CARDINAL ALUM CRUTCHES PUSH BTN W/ACCES ADULT
MDR report key: 1306063
·
Received February 4, 2009
Report
- Report Number
- 1219232-2009-00001
- Event Type
- Injury
- Date Received
- February 4, 2009
- Date of Event
- December 30, 2008
- Report Date
- January 26, 2009
- Manufacturer
- CAREMAX REHABILITATION EQUIP CO., LTD.
- Product Code
- IPR
- Product Problem
- Yes
- Report Source
- Distributor report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
END USER WAS AT THEIR RESIDENCE USING THE CRUTCHES DUE TO THEIR RECENT FOOT SURGERY, WHICH INCLUDED A WIRE SET UP. WHILE IN USE, THE CRUTCH TUBING BROKE THROUGH THE TIP AND GOT CAUGHT ON THE CARPET. THIS CAUSED THE END USER TO FALL; THE WIRE ENDED UP IN A POSITION WHERE ADDITIONAL SURGERY WAS NEEDED TO PULL IT OUT AND BE RESET.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CARDINAL ALUM CRUTCHES PUSH BTN W/ACCES ADULT | CRUTCHES | IPR | CAREMAX REHABILITATION EQUIP CO., LTD. | 75-1435-0001 | 082122 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 41 YR | Hospitalization| R |