Sinu-foam RR 650Recalls & reported problems
Smith & Nephew, Inc. · SINU FOAM · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00817470000412), received between Dec 5, 2017 and Nov 13, 2018 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Contamination /Decontamination 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 16, 2026.
Most reported problems
Device problems
- Contamination /Decontamination Problem1
- Device Operates Differently Than Expected1
- Material Integrity Problem1
Patient problems
- Fungus1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryNov 13, 2018Contamination /Decontamination Problem; Material Integrity Problem
IT WAS REPORTED THAT ANOTHER SURGERY HAD TO BE MADE TO REMOVE SINUS FOAM SINCE THIS CAUSED GROWTH OF FUNGUS IN NASAL CAVITY.
Patient problems: Fungus
MAUDE report 8064155 ↗MalfunctionDec 5, 2017Device Operates Differently Than Expected
IT WAS REPORTED THAT DESPITE MIXING THE STAMMBERGER SINUFOAM RR650 WITH STERILE WATER AS SHE HAD IN THE PAST, IT DID NOT DISSOLVE BUT STAYED IN ITS FULL FORM. THERE WAS NO PATIENT INJURY REPORTED. THERE WAS NO BACKUP DEVICE AVAILABLE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7083033 ↗
Other SPLINT, INTRANASAL SEPTAL devices
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- Nasopore 5400010008Stryker Corporation · SPLINT, INTRANASAL SEPTAL1 recall4 reports
- Nasopore 5400020108Stryker Corporation · SPLINT, INTRANASAL SEPTAL1 recall3 reports
- Hemopore 5400020208Stryker Corporation · SPLINT, INTRANASAL SEPTAL1 recall3 reports
- Nasopore 5400222004SStryker Corporation · SPLINT, INTRANASAL SEPTAL1 recall0 reports
- Nasopore 5400010004Stryker Corporation · SPLINT, INTRANASAL SEPTAL1 recall0 reports
- Nasopore 5400020004Stryker Corporation · SPLINT, INTRANASAL SEPTAL1 recall0 reports
- Nasopore 5400030004Stryker Corporation · SPLINT, INTRANASAL SEPTAL1 recall0 reports
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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