FDA Adverse Event
Malfunction
Summary report: N
ENDURANCE HD WALKER
MDR report key: 1513339
·
Received October 12, 2009
Report
- Report Number
- 1056127-2009-00018
- Event Type
- Malfunction
- Date Received
- October 12, 2009
- Date of Event
- September 14, 2009
- Report Date
- September 16, 2009
- Manufacturer
- ESSENTIAL MEDICAL SUPPLY, INC.
- Product Code
- ITJ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PATIENT USES ROLLATOR AS A TRANSPORTATION DEVICE, EVEN THOUGH HE HAS A WHEELCHAIR AVAILABLE TO HIM. HE TRANSPORTS HIMSELF OVER A VARIETY OF SURFACES. MULTIPLE MEDICAL DIAGNOSIS CONTRAINDICATE USE OF ROLLATOR.
Description of Event or Problem · 1
PATIENT STATES HE ROLLED INTO ELEVATOR AT HIS APARTMENT, TURNED AROUND TO SIT ON WALKER AND CASTER CAME OFF.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDURANCE HD WALKER | ROLLATOR | ITJ | ESSENTIAL MEDICAL SUPPLY, INC. | W1801 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 56 YR |