FDA Adverse Event
Injury
Summary report: N
DIGITALDIAGNOST
MDR report key: 2423260
·
Received January 17, 2012
Report
- Report Number
- 3003768251-2012-00001
- Event Type
- Injury
- Date Received
- January 17, 2012
- Date of Event
- January 5, 2012
- Report Date
- January 11, 2012
- Manufacturer
- PHILIPS MEDICAL SYSTEMS DMC GMBH
- Product Code
- MQB
- PMA / PMN Number
- K982795
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
WHEN INVESTIGATION IS COMPLETED A F/U REPORT WILL BE SENT TO THE FDA. (B)(4).
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT WHEN USING THE PT CARRIAGE THE MOVABLE FOOTBOARD, WHICH WAS IN A VERTICAL POSITION, DID NOT STAY IN POSITION AND MOVED DOWN TOWARDS THE FLOOR. THIS RESULTED IN A BROKEN TOE ON THE RIGHT FOOT OF THE USER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DIGITALDIAGNOST | MQB | PHILIPS MEDICAL SYSTEMS DMC GMBH | 712050 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |