OtherLIO
ORASURE ORAL SPECIMEN COLLECTION DEVICE
Received Jan 18, 2006 · Event occurred Dec 22, 2005
Report 2528909-2006-00001 · MDR key 666759
Device
Generic name
Oral Fluid Collection
Manufacturer
Orasure Technologies, Inc.Model number
503-0050Catalog number
*
Lot number
0105343
Product problems
- Unknown (for use when the device problem is not known)
Patient
49 YR
- Pain
- Swelling
- Treatment with medication(s)
Narrative
Description of Event or Problem
IN THE AFTERNOON OF 12/05 A FEMALE USED AN ORASURE COLLECTION DEVICE FOR A ORAL FLUID SPECIMEN COLLECTION. LATER THAT EVENING THE WOMAN WENT TO THE EMERGENCY ROOM REPORTING SWELLING ON HER FACE AND PAIN BEHIND HER EAR ON THE SIDE THAT SHE SWABBED WITH THE COLLECTION DEVICE. THE EMERGENCY ROOM PHYSICIAN PRESCRIBED AN ANTIBIOTIC AND A LEMON DROP TO MAKE THE SALIVA GLAND WORK OVERTIME. THE WOMAN WAS BACK TO WORK THE NEXT MORNING WITHOUT ANY ADVERSE RESULTS.