FDA Adverse Event
Injury
Summary report: N
DRIVE ROLLER WALKER
MDR report key: 8955757
·
Received August 30, 2019
Report
- Report Number
- MW5089494
- Event Type
- Injury
- Date Received
- August 30, 2019
- Date of Event
- August 13, 2019
- Report Date
- August 30, 2019
- Manufacturer
- DRIVE DEVILBISS HEALTHCARE / MEDICAL DEPOT, INC.
- Product Code
- ITJ
- Adverse Event
- Yes
- Report Source
- Voluntary report
- Reporter Location
- UT, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
SUBMITTER WAS USING THE PRODUCT IN HER BACK YARD. OUT OF NOWHERE THE BACK LEFT LEG OF THE WALKER BROKE AND CAUSED THE SUBMITTER TO FALL. DID NOT SUSTAIN ANY MAJOR INJURIES. MINOR CUTS AND BRUISES ON THE ARMS AND LEGS. SUBMITTER BELIEVES THIS PRODUCT IS A FALL HAZARD. PURCHASE DATE: (B)(6) 2014 - THIS DATE IS AN ESTIMATE. DOCUMENT NUMBER: (B)(6). REPORT NUMBER: (B)(6).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 746208 | DRIVE ROLLER WALKER | WALKER MECHANICAL | ITJ | DRIVE DEVILBISS HEALTHCARE / MEDICAL DEPOT, INC. | ROLLER WALKER |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |