FDA Adverse Event
Injury
Summary report: N
MOBILEDIAGNOST WDR
MDR report key: 3522419
·
Received December 4, 2013
Report
- Report Number
- 1217116-2013-00002
- Event Type
- Injury
- Date Received
- December 4, 2013
- Date of Event
- November 5, 2013
- Report Date
- November 11, 2013
- Manufacturer
- SEDECAL SA
- Product Code
- IZL
- Adverse Event
- Yes
- Report Source
- Distributor report
- Reporter Location
- NL
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
PHILIPS REC'D A REPORT FROM A CUSTOMER THAT AN OPERATOR BROKE HER NOSE WHILE HANDLING THE MOBILE. SHE WANTED TO ROTATE THE TUBE AFTER AN EXAMINATION OF A PT INTO THE PARKING POSITION. SHE TURNED THE TUBE IN THE WRONG DIRECTION. THE SUDDEN STOP OF TUBE ROTATION CONTRIBUTED TO THE BROKEN NOSE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 628756 | MOBILEDIAGNOST WDR | NONE | IZL | SEDECAL SA | 712001 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |