FDA Adverse Event
Injury
Summary report: N
FLAMINGO
MDR report key: 3173444
·
Received May 2, 2013
Report
- Report Number
- 3001657382-2013-00003
- Event Type
- Injury
- Date Received
- May 2, 2013
- Date of Event
- April 6, 2013
- Report Date
- May 1, 2013
- Manufacturer
- R82 A/S
- Product Code
- INM
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FI
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THIS INFO IS ALSO SENT TO (B)(4), (B)(6), WHERE THE INCIDENT TOOK PLACE.
Description of Event or Problem · 1
"THE GIRL WAS SITTING ON THE CHAIR AND SHE SWINGS FORWARD/BACKWARD A LOT, WITHOUT ANY WARNING SEAT LOCKS UNDER THE SEAT BROKE, THE GIRL MOVES FORWARD AND THE WHOLE CHAIR TIPPED OVER AND GIRL HIT HER HEAD ON THE FLOOR OF THE SHOWER ROOM. THE TEETH COMING ON HER LIP AND THREE OF THEM ARE BROKEN."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 193556 | FLAMINGO | FLAMINGO | INM | R82 A/S | 880003-NL |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 12 YR | Hospitalization |