FDA Adverse Event
Injury
Summary report: N
ROLLATOR WALKER
MDR report key: 9193289
·
Received October 11, 2019
Report
- Report Number
- MW5090395
- Event Type
- Injury
- Date Received
- October 11, 2019
- Date of Event
- July 26, 2019
- Report Date
- October 11, 2019
- Manufacturer
- NOVA ORTHO-MED, INC.
- Product Code
- ITJ
- Adverse Event
- Yes
- Report Source
- Voluntary report
- Reporter Location
- MD, US
- Reporter Occupation
- PATIENT
Narratives
Description of Event or Problem · 1
REPORTER STATED THAT SHE WAS TRYING TO GO TO THE LIVING ROOM IN HER APARTMENT USING A ROLLATOR AND THE ARM BROKE AND SHE FELL DOWN ON THE FLOOR. AS A RESULT, HER FAKE HIP RAMMED THROUGH HER PELVIS. REPORTER STATED SHE WAS TAKEN TO THE TRAUMA CENTER TO HAVE SURGERY TO FIX THE PROBLEM. HOWEVER, THE DRS COULD NOT PULL IT BACK SO THEY LEFT IT THE WAY IT WAS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 972032 | ROLLATOR WALKER | WALKER, MECHANICAL | ITJ | NOVA ORTHO-MED, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR | Hospitalization |