FDA Adverse Event
Injury
Summary report: N
DRIVE ROLLATOR WALKER
MDR report key: 20360491
·
Received October 2, 2024
Report
- Report Number
- MW5160486
- Event Type
- Injury
- Date Received
- October 2, 2024
- Date of Event
- September 20, 2024
- Report Date
- September 27, 2024
- Manufacturer
- MEDICAL DEPOT INC. DBA DRIVE DEVILBISS HEALTHCARE
- Product Code
- ITJ
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- CA, US
- Reporter Occupation
- PATIENT FAMILY MEMBER OR FRIEND
- Health Professional
- *
Narratives
Description of Event or Problem · 0
I WAS ASSISTING MY MOTHER FROM A SEATED POSITION TO A STANDING POSITION USING HER WALKER AND THE FRONT RIGHT WHEEL COMPONENT COMPLETELY BROKE OFF CAUSING THE FRONT OF THE WALKER TO SHIFT FORWARD ABRUPTLY. THIS COULD HAVE RESULTED IN A FALL AND PROBABLE HEAD INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2602400 | DRIVE ROLLATOR WALKER | WALKER, MECHANICAL | ITJ | MEDICAL DEPOT INC. DBA DRIVE DEVILBISS HEALTHCARE | R728RD |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 86 YR | Female | Life Threatening | CRANBERRY.| D-MANNOSE.| GLIPIZIDE.| GLUCOCIL.| IRON.| LYRICA.| MELATONIN.| METOPROLOL.| MULTIVITAMINS.| POTASSIUM.| PROBIOTICS.| SEROQUEL.| VICTOZA.| ZETIA. |