MicroFrance® 7803S-2Recalls & reported problems
Integra Microfrance · TONGUE DEPRESSOR 7803S-2 N2 KILNER · Class 1
Data updated Oct 13, 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 10381780089407), received between Aug 12, 2025 and Aug 12, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Nonstandard Device” (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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Nonstandard Device1
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.
InjuryAug 12, 2025Nonstandard Device; Adverse Event Without Identified Device or Use Problem; Nonstandard Device; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE REQUIRING THE USE OF A KILNER TONGUE DEPRESSOR, THE TONGUE DEPRESSOR 7803S-2 N2 KILNER (7803S-2), THE SURGEON OBSERVED A WOUND ON THE TONGUE THAT REQUIRED SUTURING. THE LOCATION OF THE LESION COINCIDES WITH THE POINT OF CONTACT OF THE DEVICE. IT WAS REPORTED THAT DURING INSPECTION OF THE BLADES, THE SURGEON NOTED THAT THEY HAD A PARTICULARLY SHARP EDGE. NO DEATH OR SURGICAL DELAYS WERE REPORTED.
Patient problems: Laceration(s)
MAUDE report 22782330 ↗
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- Integra® Jarit® 450110RIIntegra Lifesciences Production Corporation · GAG, MOUTH1 report
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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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