FDA Adverse Event
Injury
Summary report: N
HUGO
MDR report key: 525090
·
Received May 14, 2004
Report
- Report Number
- 2433043-2004-00001
- Event Type
- Injury
- Date Received
- May 14, 2004
- Date of Event
- April 7, 2004
- Report Date
- May 14, 2004
- Manufacturer
- CAN-AM CARE
- Product Code
- ITJ
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
THE LEFT, REAR LEG OF THE WALKER BROKE CAUSING THE PT TO FALL. THE PT REQUIRED STITCHES FOR A LACERATION TO THEIR FACE/FOREHEAD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HUGO | ROLLING WALKER | ITJ | CAN-AM CARE | V2.5 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 84 YR | Required Intervention |