FDA Adverse Event
Injury
Summary report: N
HOY-STATURE
MDR report key: 3142460
·
Received March 12, 2013
Report
- Report Number
- 3009402404-2013-00004
- Event Type
- Injury
- Date Received
- March 12, 2013
- Date of Event
- January 26, 2013
- Report Date
- February 25, 2013
- Manufacturer
- APEX HEALTHCARE MFG INC
- Product Code
- FNG
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
JOERNS HEALTHCARE WILL BE SENDING COPY OF THIS REPORT TO: LIFT MANUFACTURER [APEX HEALTHCARE MFG INC] AND THE SCALE MANUFACTURER [IMS INC (INTEGRATED MEASUREMENT SYSTEMS INC)].
Description of Event or Problem · 1
IT WAS REPORTED TO THE MANUFACTURER BY THE FACILITY, (B)(6) HEALTH AND REHAB, PER FACILITY A PIN ON THE LIFT CRADLE CAME LOOSE AND IS MISSING, THE RESIDENT FELL HIT HEAD AND WAS SENT TO THE HOSPITAL FOR MEDICAL EXAM AND THEN WAS ADMITTED. MANUFACTURER SENT A NEW SCALE AND CRADLE TO THE FACILITY. (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 104981 | HOY-STATURE | PATIENT LIFTER | FNG | APEX HEALTHCARE MFG INC | HOT-STATURE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Hospitalization |