FDA Adverse Event
Injury
Summary report: N
MAXISKY 600
MDR report key: 3162307
·
Received May 10, 2013
Report
- Report Number
- 1419652-2013-00119
- Event Type
- Injury
- Date Received
- May 10, 2013
- Date of Event
- May 2, 2013
- Report Date
- May 2, 2013
- Manufacturer
- ARJOHUNTLEIGH MAGONG INC
- Product Code
- FSA
- Adverse Event
- Yes
- Report Source
- Distributor report
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
THE RESIDENT WAS BEING TRANSFERRED WITH THE CEILING LIFT FROM THE BED TO A THERAPEUTIC CHAIR. DURING THE TRANSFER, THE CLIP SUPPORTING THE RIGHT UPPER LEG DETACHED AND THE RESIDENT TIPPED BACK TO THE RIGHT HAND SIDE. SHE DROPPED OUT OF THE SLING WITH THE BACK OF HER HEAD HIT THE FRONT EDGE OF THE NIGHT TABLE WHICH CAUSED AN INTENSIVE BLEEDING HEAD WOUND. REF MFR # 9681684-2013-00044.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 209456 | MAXISKY 600 | MAFNUFACTURED CEILING FIXED CASSETTES | FSA | ARJOHUNTLEIGH MAGONG INC | LD10003 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 78 YR | Hospitalization |