FDA Adverse Event
Injury
Summary report: N
CAREVO
MDR report key: 3952405
·
Received June 18, 2014
Report
- Report Number
- 1419652-2014-00175
- Event Type
- Injury
- Date Received
- June 18, 2014
- Date of Event
- June 5, 2014
- Report Date
- June 6, 2014
- Manufacturer
- ARJOHUNTLEIGH POLSKA SP. Z O.O.
- Product Code
- FNG
- Adverse Event
- Yes
- Report Source
- Distributor report
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED BY THE COMPANY REPRESENTATIVE: "PATIENT WAS SUPPORTED FROM NURSING STAFF INTO THE SHOWER TROLLEY FOR TAKING A SHOWER. TO DRY HIS BACK, HE WAS MOVED ON THE LEFT SIDE, HE KEPT HOLDING AT THE DROP SIDE FRAME. THE DROP SIDE FRAME LOOSENED, DROPPED DOWN AND THE PATIENT FELL DOWN ON THE FLOOR. MAYBE THE REAR LOCKING WAS NOT COMPLETELY LOCKED IN PLACE AND PATIENT LOOSENED THE FRONT LOCKING BY HOLDING HIMSELF AT THE SIDE FRAME, SO THAT THE SIDE FRAME COULD DROP DOWN." REFERENCE MFR # 3007420694-2014-00073.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 357510 | CAREVO | FNG | ARJOHUNTLEIGH POLSKA SP. Z O.O. | BAC1111-01 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 76 YR | Hospitalization |