FDA Adverse Event
Injury
Summary report: N
OHMEDA PEDIATRIC AEROSOL TENT
MDR report key: 428767
·
Received November 21, 2002
Report
- Report Number
- 1121732-2002-00007
- Event Type
- Injury
- Date Received
- November 21, 2002
- Date of Event
- October 11, 2002
- Report Date
- November 21, 2002
- Manufacturer
- OHMEDA MEDICAL
- Product Code
- FNC
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
A RESPIRATORY THERAPIST ("R.T.") REPORTED THAT AS THEY WERE MOVING THE SUBJECT DEVICE INTO AN ELEVATOR THE WHEEL CAME OFF. THERE WAS NO PATIENT IN THE UNIT. THE R.T. ALLEGEDLY TRIED TO BALANCE THE EQUIPMENT BUT IT COLLAPSED ON THEM, CAUSING A SEVERE CUT TO THEIR LEG THAT REQUIRED 28 STITCHES. THE WOUND SUBSEQUENTLY BECAME INFECTED AND CAUSED THE R.T. TO MISS SEVERAL DAYS OF WORK. THE DAMAGED PARTY WAS SPECIFICALLY REQUESTING FINANCIAL COMPENSATION FOR THEIR INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | OHMEDA PEDIATRIC AEROSOL TENT | PEDIATRIC AEROSOL TENT | FNC | OHMEDA MEDICAL | 370 | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other |