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SICAT OPTISLEEP 10401Recalls & reported problems

SiCAT GmbH & Co. KG · Class 2

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI D776104010), received between May 31, 2017 and May 31, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Fracture” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Fracture1

Patient problems

  • No Consequences Or Impact To Patient1

Recent adverse event reports

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

  • MalfunctionMay 31, 2017Fracture; Fracture

    THE REPORTING DENTIST REPORTS THAT A SICAT OPTISLEEP ANTI-SNORING DEVICE BROKE WHILE THE PATIENT WAS SLEEPING. AT THE DISTOLINGUAL EDGE OF THE OPTISLEEP DEVICE A PIECE OF ABOUT 2 X 5 MM BROKE OFF. THE PATIENT DID NOT SWALLOW OR ASPIRATE ANY PIECES.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 6600319 ↗

Other Device, Anti-Snoring devices

All Device, Anti-Snoring devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.