FDA Adverse Event
Injury
Summary report: N
JUNO DRF
MDR report key: 5080784
·
Received September 16, 2015
Report
- Report Number
- 1217116-2015-00002
- Event Type
- Injury
- Date Received
- September 16, 2015
- Date of Event
- August 6, 2015
- Report Date
- August 6, 2015
- Manufacturer
- VILLA SISTEMI MEDICALI S.P.A.
- Product Code
- KXJ
- Adverse Event
- Yes
- Report Source
- Distributor report
- Reporter Location
- TX, US
- Reporter Occupation
- RADIOLOGIC TECHNOLOGIST
Narratives
Description of Event or Problem · 1
PHILIPS WAS INFORMED BY A CUSTOMER THAT THE FOOTBOARD OF THE DEVICE DETACHED FROM THE TABLE TOP WHILE A PATIENT WAS POSITIONED ON THE TABLE. AS A RESULT THE PATIENT FELL FROM THE TABLE AND PATIENT'S HEAD AND BACK WAS INJURED. THE PATIENT WAS MOVED TO ER FOR EXAMINATION AND A MUSCLE RELAXANT WAS PRESCRIBED. THE PATIENT WAS ASKED FOR A FOLLOW UP VISIT AFTER A FEW DAYS
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 612655 | JUNO DRF | TABLE, RADIOLOGIC | KXJ | VILLA SISTEMI MEDICALI S.P.A. | 709020 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |