FDA Adverse Event
Malfunction
Summary report: N
PHILIPS BURTON MEDICAL PRODUCTS
MDR report key: 2172052
·
Received July 18, 2011
Report
- Report Number
- MW5021415
- Event Type
- Malfunction
- Date Received
- July 18, 2011
- Date of Event
- July 8, 2011
- Report Date
- July 18, 2011
- Manufacturer
- PHILIPS BURTON MEDICAL
- Product Code
- FTD
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- IL, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
THE OVERHEAD LIGHT WAS USED IN EXAMINING THE PT; UPON COMPLETION OF THE PT'S EXAMINATION, THE LIGHT WAS BEING MOVED ASIDE WHEN IT DROPPED DOWN FROM THE CEILING AND THE ARM THE LIGHT WAS ATTACHED TO WAS HELD IN PLACE BY ELECTRICAL WIRING; LARGE PART OF LIGHT STRUCK PT IN THE FACE. THE PT CRIED IMMEDIATELY, EXPERIENCED NO LOSS OF CONSCIOUSNESS. HIS LEFT EYE WAS FOUND TO HAVE SOME SWELLING INFERIORLY AND A SMALL APPROXIMATELY 1/4 CM SUPERFICIAL ABRASION. NO ACTIVE BLEEDING. NO CHANGE IN JAW/MOUTH EXAM. THE PT MOVED TO A NEW ROOM IMMEDIATELY FOR FURTHER CARE. ARM MODEL # 0102540, LIGHT MODEL 0224100.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PHILIPS BURTON MEDICAL PRODUCTS | EXAM LIGHT | FTD | PHILIPS BURTON MEDICAL | |||
| 2 | PHILIPS BURTON MEDICAL PRODUCTS | ARM | FTD | PHILIPS BURTON MEDICAL | ARM# 0102540 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 4 YR | Other |