ORASURE HIV-1 ORAL SPECIMEN COLLECTION DEVICE
Received May 17, 2000 · Event occurred May 20, 1997
Report 3023752-2000-00002 · MDR key 278384
Device
Generic name
Oral Fluid Specimen Collection Device
Manufacturer
Epitope, Inc.Model number
503-0011Catalog number
NA
Lot number
K126
Product problems
- Reaction
- Other (for use when an appropriate device code cannot be identified)
Patient
UNKNOWN
- Blister(s)
Narrative
Description of Event or Problem
A PARTICIPANT IN A CLINICAL TRIAL CONSENTED ON 05/19/1997 TO PARTICIPATE IN A STUDY. THE COMPLAINANT USED THE ORASURE HIV-1 ORAL SPECIMEN COLLECTION DEVICE, LOT NUMBER K126, AND THE ORASURE II DEVICE, LOT NUMBER P0414704, TO COLLECT ORAL FLUID SPECIMENS. FOLLOWING SUCCESSFUL COMPLETION OF THE STUDY PROCEDURES, THE SUBJECT NOTED BLISTERING OF THE ORAL TISSUES THE NEXT MORNING. THE COMPLAINANT, SUBJECT #45513 OF A CLINICAL TRIAL, REPORTED BILATERAL, PIN-HEAD SIZED BLISTERS WHERE THE ORASURE AND ORASURE II COLLECTION PADS WERE PLACED. THE COMPLAINANT FIRST REPORTED BLISTERS AT APPROX 10 AM ON 05/20/1997. THE COMPLAINANT CALLED BACK LATER AT 3 PM ON 05/20/1997 TO REPORT THAT THE BLISTERS HAD RESOLVED. THE REPORT WAS REFERRED BY THE MFR TO A MEDICAL CONSULTANT FOR REVIEW.