FDA Adverse Event
Injury
Summary report: N
DISPOSABLE ANESTHESIA BREATHING MASK
MDR report key: 280424
·
Received June 2, 2000
Report
- Report Number
- 280424
- Event Type
- Injury
- Date Received
- June 2, 2000
- Date of Event
- April 19, 2000
- Report Date
- June 2, 2000
- Manufacturer
- SIMS (SMITH INDUSTRIES)
- Product Code
- BYG
- Adverse Event
- Yes
- Report Source
- User Facility report
- Reporter Location
- MO, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
INTRAOPERATIVE FLASH FIRE DURING ECTROPION REPAIR OF EYELID RESULTING IN 2ND DEGREE FACIAL BURN. PT EXPIRED ON 5/4/00.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DISPOSABLE ANESTHESIA BREATHING MASK | OXYGEN FACE MASK | BYG | SIMS (SMITH INDUSTRIES) | * | 9N0729 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 84 YR | Hospitalization| R | 4) STERILE DRAPE (PLASTIC).| 2) STERILE GOWN AND DRAPE (PAPER),| 3) BATTERY OPERATED CAUTERY| 1) OXYGEN, |