FDA Adverse Event
Malfunction
Summary report: N
ESSENTIAL ROLLATOR
MDR report key: 2601759
·
Received April 10, 2009
Report
- Report Number
- 1056127-2008-00010
- Event Type
- Malfunction
- Date Received
- April 10, 2009
- Manufacturer
- ESSENTIAL MEDICAL SUPPLY, INC.
- Product Code
- ITJ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
REPORT INITIATED FOLLOWING FDA AUDIT.
Description of Event or Problem · 1
RIGHT FRONT CASTER DETACHED FROM UNIT, CAUSING PT TO FALL. COMPLAINT REPORTER STATED THAT THERE WAS NO INJURY BEYOND SORENESS AND BRUISING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ESSENTIAL ROLLATOR | WALKER, MECHANICAL | ITJ | ESSENTIAL MEDICAL SUPPLY, INC. | W1700 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR |