FDA Adverse Event
Malfunction
Summary report: N
GUARDIAN ROLLING WALKER
MDR report key: 1052398
·
Received May 22, 2008
Report
- Report Number
- 3006459587-2008-00014
- Event Type
- Malfunction
- Date Received
- May 22, 2008
- Date of Event
- March 24, 2008
- Report Date
- April 9, 2008
- Manufacturer
- A&E
- Product Code
- ITJ
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SC, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
FROM THE EVAL, AS THE BOLT WORKED LOOSE FROM THE LEG, THE CONTINUED USE OF THE WALKER CAUSED THE INNER THREADS OF THE LEG TO WEAR. OVER TIME, THE THREADS WERE WORN TO THE POINT WHERE THE BOLT AND CASTER ASSEMBLY BECAME DETACHED FROM THE LEG. A FIELD ACTION SUMMARY HAS BEEN SUBMITTED TO THE FDA FOR RECOMMEND CUSTOMER STRATEGY.
Description of Event or Problem · 1
THE END USER FELL AND BROKE HER LEG AFTER THE LEFT CASTER WHEEL OF THE WALKER FELL OFF.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GUARDIAN ROLLING WALKER | FOLDING WALKER | ITJ | A&E | 07886B |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |