FDA Adverse Event
Summary report: N
CHLOROPREP
MDR report key: 1840811
·
Received September 9, 2010
Report
- Report Number
- 1840811
- Date Received
- September 9, 2010
- Date of Event
- August 16, 2010
- Report Date
- September 9, 2010
- Manufacturer
- CAREFUSION
- Product Code
- KXF
- Report Source
- User Facility report
- Reporter Location
- CA, US
Narratives
Description of Event or Problem · 1
THE PATIENT WAS DRAPED AND PREPPED WITH CHLORAPREP . THE DOCTOR BEGAN A PROCEDURE TO INSERT A CATHETER IN THE PATIENT'S RIGHT CHEST. AN INCISION WAS MADE AND THE PHYSICIAN USED A BOVIE TO CAUTERIZE. THE BOTTOM PLASTIC PART OF THE DRAPE STARTED ON FIRE. THE PHYSICIAN DISCONTINUED USE OF THE CAUTERY EXTINGUISHED THE FLAMES. THIS ALL TOOK JUST ABOUT 1 SECOND AND THE FLAME WAS OUT. THE PHYSICIAN INSPECTED THE PATIENT AND DID NOT SEE ANY EVIDENCE THAT THE PATIENT WAS BURNED.====================== HEALTH PROFESSIONAL'S IMPRESSION======================THE CAUTERY CAUSED THE CHLORAPREP TO CATCH ON FIRE.====================== MANUFACTURER RESPONSE FOR SKIN PREP, CHLORAPREP======================THANKS
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CHLOROPREP | SKIN PREP | KXF | CAREFUSION | * | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 12 MO |