FDA Adverse Event
Injury
Summary report: N
MAXI SKY 600
MDR report key: 1884966
·
Received October 22, 2010
Report
- Report Number
- 9681684-2010-00046
- Event Type
- Injury
- Date Received
- October 22, 2010
- Date of Event
- October 3, 2010
- Report Date
- October 4, 2010
- Manufacturer
- BHM MEDICAL INC.
- Product Code
- FSA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
FURTHER INFORMATION WILL BE PROVIDED UPON MANUFACTURER'S INVESTIGATION.
Description of Event or Problem · 1
WHILE TWO CAREGIVERS WERE ASSISTING A PATIENT DURING A TRANSFER FROM WHEELCHAIR TO BED, THE LEFT SHOULDER CLIP DETACHED AND THE PATIENT, WHO WAS PARTIALLY OVER THE BED, FELL. SHE WAS TAKEN TO HOSPITAL AND SUSTAINED A SPIRAL FRACTURE TO THE LEFT FEMUR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MAXI SKY 600 | LIFT, PATIENT, NON-AC POWERED | FSA | BHM MEDICAL INC. | LD10001 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 88 YR | Hospitalization| O| R |