FDA Adverse Event
Other
Summary report: N
GOLVO
MDR report key: 934513
·
Received October 24, 2007
Report
- Report Number
- 3006252983-2007-00008
- Event Type
- Other
- Date Received
- October 24, 2007
- Date of Event
- October 13, 2007
- Report Date
- October 15, 2007
- Manufacturer
- LIKO NORTH AMERICA
- Product Code
- FSA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
ON-SITE INVESTIGATION WAS PERFORMED BY LIKO DISTRIBUTOR ON 10/16/2007, IN WHICH HE WAS ALLOWED TO VIEW AND EXAMINE THE LIFT AND SLING INVOLVED IN THE REPORTED INCIDENT. THE EQUIPMENT WAS FOUND TO BE IN GOOD WORKING CONDITION. WHEN USED PER MANUFACTURERS INSTRUCTIONS, THE INCIDENT COULD NOT BE RECREATED BY THE FACILITY STAFF.
Description of Event or Problem · 1
FACILITY REPORTS THAT IN 2007, WHILE TRANSFERRING A RESIDENT FROM BED TO CHAIR USING A GOLVO 7007, THAT THE SLING CAME OFF AND THE RESIDENT FELL TO THE FLOOR. RESIDENT SUFFERED LACERATION TO THE HEAD, ELBOW AND ARM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GOLVO | PATIENT LIFT | FSA | LIKO NORTH AMERICA | GOLVO 7007 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | YR | Other |