FDA Adverse Event
Malfunction
Summary report: N
POWER LOAD
MDR report key: 3781590
·
Received April 30, 2014
Report
- Report Number
- 0001831750-2014-02945
- Event Type
- Malfunction
- Date Received
- April 30, 2014
- Date of Event
- April 6, 2014
- Report Date
- April 6, 2014
- Manufacturer
- STRYKER MEDICAL-KALAMAZOO
- Product Code
- FPO
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
IT WAS ALLEGED THAT A MEDIC HAD INJURED THEIR FINGER WHILE USING THE POWER-LOAD. THE USER FACILITY DETERMINED THAT THE EVENT WAS CAUSED BY LACK OF TRAINING AND THE USER FACILITY HAS ADDRESSED THE ISSUE INTERNALLY. NO DEFECT WITH THE DEVICE WAS ALLEGED.
Description of Event or Problem · 1
IT WAS REPORTED THAT A MEDIC INJURED THEIR FINGER WHILE USING THE POWER-LOAD SYSTEM. NO PATIENT. INVOLVEMENT WAS REPORTED. NO FURTHER INFORMATION REGARDING THE INJURY WAS PROVIDED.
Description of Event or Problem · 1
IT WAS REPORTED THAT A MEDIC INJURED THEIR FINGER WHILE USING THE POWER-LOAD SYSTEM. NO PATIENT. INVOLVEMENT WAS REPORTED. NO FURTHER INFORMATION REGARDING THE INJURY WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 260095 | POWER LOAD | STRETCHER, WHEELED | FPO | STRYKER MEDICAL-KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |