EPISCREEN HIV-1 ORAL SPECIMEN COLLECTION DEVICE
Received May 17, 2000 · Event occurred Sep 3, 1997
Report 3023752-2000-00004 · MDR key 278381
Device
Generic name
Oral Fluid Specimen Collection Device
Manufacturer
Epitope, Inc.Model number
503-0031Catalog number
NA
Lot number
UNK
Product problems
- Reaction
- Other (for use when an appropriate device code cannot be identified)
Patient
UNKNOWN
- Blister(s)
- Irritation
- Increased Sensitivity
- Soreness
- Other (for use when an appropriate patient code cannot be identified)
Narrative
Description of Event or Problem
ON 9/3/1997, AN INSURANCE AGENT COLLECTED AN ORAL FLUID SPECIMEN FROM A CLIENT USING THE EPISCREEN HIV-1 ORAL FLUID SPECIMEN COLLECTION DEVICE. ON 9/4/1997, THE PARENT OF THE CLIENT REPORTED BACK TO THE INSURANCE AGENT THAT THE CLIENT'S MOUTH WAS RAW AND HAD WHITE BLISTERS IN THE AREA WHERE THE COLLECTION PAD HAD BEEN PLACED. WHITE BLISTERS WERE STILL PRESENT ON 9/5/1997 AND THE AREA WAS SORE AND SENSITIVE TO SALT OR SPICY FOOD ON 9/11/1997 WHEN THE COMPLAINT WAS RECEIVED. IT WAS REPORTED THAT THE AGENT HAD INSTRUCTED THE CLIENT TO RUB THE COLLECTION PAD BACK AND FORTH SEVERAL TIMES. ALSO, THE AGENT THOUGHT THAT IT WAS POSSIBLE THAT THE CLIENT HAD RUBBED THE PAD TOO VIGOROUSLY AND HAD CAUSED IRRITATION. A MATERIAL SAFETY DATA SHEET FOR THE COLLECTION PAD INGREDIENTS WAS SENT TO THE INITIAL REPORTER OF THE INCIDENT. THE INSURANCE AGENT SPOKE WITH THE CLIENT'S PARENT AND REPORTED BACK THAT THE CLIENT WAS FINE AND THAT CLIENT HAD NO FURTHER CONCERNS. THIS WAS COMMUNICATED TO THE MFR ON 11/17/1997.