FDA Adverse Event
Injury
Summary report: N
NON AC-POWERED PATIENT LIFT
MDR report key: 3884553
·
Received June 19, 2014
Report
- Report Number
- 9616091-2014-01057
- Event Type
- Injury
- Date Received
- June 19, 2014
- Date of Event
- March 21, 2014
- Report Date
- May 21, 2014
- Manufacturer
- INVAMEX
- Product Code
- FSA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- OTHER CAREGIVERS
Narratives
Additional Manufacturer Narrative · 1
(B)(4). NO ALLEGED MALFUNCTION AS PATIENT GRABBED SLING STRAP CAUSING IT TO COME OFF THE LIFT. MGMT CALLED FACILITY BACK AND PROVIDED REQUESTED INFORMATION. NO FURTHER DETAIL PROVIDED AT THIS TIME.
Description of Event or Problem · 1
FACILITY STATES PATIENT GRABBED THE SLING STRAP CAUSING IT TO COME OFF THE HANGER BAR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 360721 | NON AC-POWERED PATIENT LIFT | 880.5510 | FSA | INVAMEX | RPA450-1 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |