MicroFrance® MCL206A5Recalls & reported problems
Integra Microfrance · TONGUE DEPRESSOR MCL206A5 35X65MM · Class 1
All models of MicroFrance (22)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10381780105275), received between Jul 8, 2025 and Jul 8, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Material Split, Cut or Torn” (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.
Reports received per month
Most reported problems
Device problems
- Material Split, Cut or Torn1
Patient problems
- Laceration(s)1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJul 8, 2025Material Split, Cut or Torn; Material Split, Cut or Torn
A FACILITY REPORTED THAT DURING A TRANS-ORAL-ROBOTIC SURGERY, A MOUTH GAG WAS PLACED USING THE TONGUE DEPRESSOR MCL206A5 35X65MM (MCL206A5) AND THE SUSPENSION APPARATUS. IT WAS REPORTED THAT, AT THE CONCLUSION OF THE SURGERY, THE MOUTH GAG WAS REMOVED, AND THERE WERE TWO SMALL LACERATIONS ON THE PATIENT'S TONGUE, WHICH WERE BELIEVED TO BE CAUSED BY THE ROUNDED CORNERS OF THE MCL206A5 SOLID TONGUE BLADE, WHICH REQUIRED A COUPLE OF STITCHES IN BOTH LOCATIONS TO CLOSE AND PREVENT FURTHER BLEEDING. NO DEATH OR SURGICAL DELAY WAS REPORTED.
Patient problems: Laceration(s)
MAUDE report 22439195 ↗
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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