EPISCREEN HIV-1 ORAL SPECIMEN COLLECTION DEVICE
Received May 17, 2000 · Event occurred Jan 25, 1998
Report 3023752-2000-00006 · MDR key 278632
Device
Generic name
Oral Fluid Specimen Collection
Manufacturer
Epitope, Inc.Model number
503-0031Catalog number
NA
Lot number
UNK
Product problems
- Other (for use when an appropriate device code cannot be identified)
- Unknown (for use when the device problem is not known)
Patient
20 YR
- Swelling
- Therapy/non-surgical treatment, additional
- Treatment with medication(s)
Narrative
Description of Event or Problem
AN INSURANCE AGENT REPORTED THAT A CLIENT HAD COLLECTED AN ORAL FLUID SAMPLE USING THE EPISCREEN DEVICE ON 1/23/1998. ON 1/25/1998, AT 10 AM, THE COMPLAINANT WAS TAKEN BY THE PARENT TO THE EMERGENCY ROOM OF THE HOSP DUE TO FACIAL SWELLING OF THE FACE WHERE THE DEVICE WAS PLACED. THE DR GAVE PT TWO INJECTIONS AND STEROID PILLS TO TAKE FOR A WEEK. THE PARENT OF THE COMPLAINANT REQUESTED TO KNOW IF THE DEVICE COULD HAVE CAUSED AN ALLERGIC REACTION. AS OF 2/16/1998, THE PARENT OF THE COMPLAINANT REPORTED THAT PT HAD NO FURTHER SYMPTOMS.