EPISCREEN HIV-1 ORAL SPECIMEN COLLECTION DEVICE
Received May 17, 2000 · Event occurred Oct 18, 1998
Report 3023752-2000-00014 · MDR key 278508
Device
Generic name
Oral Fluid Specimen Collection Device
Manufacturer
Epitope, Inc.Model number
503-0031Catalog number
NA
Lot number
UNK
Product problems
- Unknown (for use when the device problem is not known)
Patient
UNKNOWN
- Rash
- Treatment with medication(s)
- Hospitalization required
Narrative
Description of Event or Problem
THE COMPLAINANT'S SPOUSE REPORTED THAT THEIR SPOUSE HAD PROVIDED AN EPISCREEN ORAL FLUID SPECIMEN ON 10/13/1998. ON 10/18/1998, THE COMPLAINANT BROKE OUT IN A RASH AND WAS TAKEN TO THE HOSPITAL WHERE COMPLAINANT WAS TREATED WITH BENADRYL. THE SYMPTOMS WENT AWAY BUT RETURNED ON 10/19/98 WHICH REQUIRED ANOTHER TRIP TO THE HOSPITAL. THE COMPLAINANT'S REPORTED THAT NOTHING OUT OF THE ORDINARY HAD OCCURRED TO THEIR SPOUSE EXCEPT FOR THE ORAL SPECIMEN COLLECTION. THE MANUFACTURER SENT THE INSURANCE REPRESENTATIVE A COPY OF THE MSDS.