Oral-Eze Collection System 96100-050Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00884883012653), received between Aug 17, 2017 and Aug 17, 2017 — classified as 1 injury.

The most frequently reported specific device problem is “Chemical Problem” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryAug 17, 2017Chemical Problem; Chemical Problem

  A USER ALLEGES THAT ON (B)(6) 2017, DURING THE USE OF PAD/STICK COMPONENT OF THE "ORAL EZE DRUG TEST", BLUE DIE LEAKED INSIDE HIS MOUTH. DURING THE FIRST HOUR AFTER THE LEAKAGE, THE LEFT SIDE OF HIS FACE FELT NUMB. HOURS LATER, HE WOKE UP IN THE MIDDLE OF THE NIGHT WITH WHOLE FACE NUMB FROM LEFT EYE AND FOREHEAD AREA AND NERVE PAIN. THE USER WENT TO EMERGENCY ROOM THE NEXT DAY ON (B)(6) 2017, MEDICATION WAS GIVEN TO THE USER AND THE HEALTH CONDITION DID NOT IMPROVE. HE REPORTED THAT OVER THE NEXT 2 WEEKS, HIS CONDITION DID NOT APPEAR TO IMPROVE. DURING THE THIRD WEEK THE MEDICAL CONDITION WAS OBSERVED WITH SOME IMPROVEMENT TO THE LEFT EYE. THE USER ALLEGES THE DOCTORS STATED THAT THE CONDITION COULD BE 6 WEEKS LONG TO 6 MONTHS CONDITION TO EVEN PERMANENT PARALYSIS. SEVERAL ATTEMPTS WERE MADE TO GATHER ADDITIONAL INFORMATION ABOUT THE SUBJECT, THE DEVICE USED, DURATION OF THE TIME THE DEVICE WAS IN SUBJECTS MOUTH. WE HAVE NOT BEEN ABLE TO OBTAIN ANY FURTHER INFORMATION TO INVESTIGATE THIS EVENT.

  Patient problems: Anaphylactoid / Anaphylaxis; Anxiety; Facial Nerve Paralysis

  MAUDE report 6800845 ↗