FDA Adverse Event
Injury
Summary report: N
HOYER STATURE
MDR report key: 6995655
·
Received November 2, 2017
Report
- Report Number
- 3010605276-2017-00005
- Event Type
- Injury
- Date Received
- November 2, 2017
- Date of Event
- September 21, 2017
- Report Date
- November 1, 2017
- Manufacturer
- APEX HEALTH CARE MFG., INC.
- Product Code
- FSA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- SERVICE PERSONNEL
Narratives
Description of Event or Problem · 1
WE RECEIVED THE MEDWATCH FORM 3500A FROM OUR CUSTOMER: JOERNS HEALTHCARE AND IT STATED AS BELOW: IT WAS REPORTED TO THE MANUFACTURER BY THE END USER, PER THE END USER, STAFF WAS LIFTING THE PATIENT AND THE LEG OF THE LIFT SNAPPED OFF AND THE PATIENT FEEL TO THE FLOOR. THE PATIENT WAS SENT TO THE HOSPITAL AND SUSTAINED A FRACTURED RIGHT HIP. IT WAS ENTERED INTO JOERNS SYSTEM TO HAVE THE LIFT RETURNED TO JOERNS FOR INVESTIGATION. AS OF THIS WRITING, WE HAVE NOT YET OBTAINED THE UPDATE NEWS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 776118 | HOYER STATURE | PATIENT LIFT, PRODUCT CODE: FSA | FSA | APEX HEALTH CARE MFG., INC. | HOY-STATUREWSC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization |