FDA Adverse Event
Injury
Summary report: N
PAL
MDR report key: 485889
·
Received September 24, 2003
Report
- Report Number
- 2132280-2003-00007
- Event Type
- Injury
- Date Received
- September 24, 2003
- Date of Event
- September 11, 2003
- Report Date
- September 16, 2003
- Manufacturer
- SUNRISE MACHINE AND TOOL, INC.
- Product Code
- FSA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
RESIDENT WAS BEING LIFTED USING THE HOYER LIFT WHEN THE METAL HOOK (LEFT SIDE FACING HOYER) HOLDING THE SLING BROKE OFF. WHEN THE HOOK BROKE RESIDENT TIPPED TO LEFT SIDE, HEAD WENT BACK AND BUMPED BAR OF HOYER, BODY TURNED & RESIDENT FELL BACK TO FLOOR HEAD FIRST. BACK OF HEAD HIT THE FLOOR FROM HEIGHT OF 2 FEET. CNA THEN LOWERED RESIDENT TO THE FLOOR. RESIDENT WAS SENT TO E.R. FOR EVAL AND RETURNED TO NURSING HOME THAT EVENING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PAL | HOYER LIFT - FULL BODY LIFT | FSA | SUNRISE MACHINE AND TOOL, INC. | PL2505R | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 82 YR | Hospitalization |