FDA Adverse Event
Malfunction
Summary report: N
CARLO COMFORT GP CARRY BAR
MDR report key: 3888659
·
Received October 18, 2013
Report
- Report Number
- 3007802293-2014-00013
- Event Type
- Malfunction
- Date Received
- October 18, 2013
- Date of Event
- April 16, 2014
- Report Date
- May 28, 2014
- Manufacturer
- BEKA HOSPITEC GMBH
- Product Code
- FSA
- Product Problem
- Yes
- Report Source
- Distributor report
- Reporter Location
- CA
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Description of Event or Problem · 1
A CARRY BAR BROKE AT THE SWIVEL CONNECTION POINT JUST AFTER THE RESIDENT HAD BEEN TRANSFERRED TO HER BED. THERE WERE NO CONSEQUENCES TO THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 537493 | CARLO COMFORT GP CARRY BAR | GP CARRY BAR | FSA | BEKA HOSPITEC GMBH | 278802 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 75 YR |