SenSura Mio 18655Recalls & reported problems
Coloplast A/S · Class 1
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 05701780003179), received between Aug 6, 2025 and Aug 6, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (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
- Insufficient Device Problem Information1
Patient problems
- Sepsis1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryAug 6, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
ACCORDING TO THE AVAILABLE INFORMATION, IN TWO SEPARATE INSTANCES WITH PRODUCTS FROM THE SAME BOX OF SENSURA MIO HIGH OUTPUT FLEX OSTOMY BAG 2-PIECE, BOTH THE CONSUMER AND HER NURSE NOTICED MOLD GROWTH ON THE SKIN. THE LOCATION ON THE SKIN WHERE THE MOLD WAS NOTICED IS NOT DESCRIBED, SO IT IS NOT KNOWN WHETHER THE MOLD WAS SEEN IN THE IMMEDIATE PERISTOMAL AREA OR FURTHER AWAY FROM THE STOMA. ON THE MOST RECENT OCCASION, THE POUCH WAS ON FOR 3 DAYS. WHEN THE CONSUMER REMOVED THE POUCH, BOTH SHE AND THE NURSE NOTICED THE MOLD. ONE WEEK LATER, THE CONSUMER WAS SENT TO THE ER WITH FATIGUE AND A FEVER OF 104ºF (40ºC). SHE WAS ADMITTED INTO THE HOSPITAL, HAD CULTURES TAKEN, AND THE DOCTORS UNCOVERED SHE WAS IN SEPTIC SHOCK. THE CONSUMER STAYED IN THE HOSPITAL FOR 3 WEEKS UNTIL SHE WAS DISCHARGED. WHEN SHE WAS AT HOME, SHE STAYED ON ANTIBIOTICS FOR A SHORT WHILE. AS OF TODAY - THE CONSUMER HAS FULLY RECOVERED FROM THE SEPTIC SHOCK. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.
Patient problems: Sepsis
MAUDE report 22728186 ↗
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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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