SenSura Mio Convex brand logo 16911Recalls & 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 05708932893299), received between Nov 21, 2023 and Nov 21, 2023 — 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
- Adverse Event Without Identified Device or Use Problem1
- Insufficient Device Problem Information1
Patient problems
- Abdominal Pain1
- Abscess1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryNov 21, 2023Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information
ACCORDING TO THE AVAILABLE INFORMATION, A USER OF UNKNOWN AGE, USED THE SENSURA MIO LIGHT CONVEX CLICK 2 PC BAG AND BASEPLATE WHERE THE PLASTIC EDGE OF THE RING ON THE PLATE GOT EMBEDDED IN THE STOMA CAUSING IMMENSE PAIN. THE USER SUFFERED FROM PAIN THE NEXT DAY AS WELL AND WAS UNABLE TO WORK. ON THE THIRD DAY, THE USER NOTICED A LEAKAGE OF PUS BETWEEN STOMA AND SKIN PROMPTING THEM TO SEEK MEDICAL INTERVENTION AT THE HOSPITAL. A CT-SCAN REVEALED AN INFLAMMATORY CONDITION AND ABSCESS WHERE THE PLATE HAD PENETRATED THE SKIN. THE USER WAS DISCHARGED THE FOLLOWING AFTERNOON AND ANTIBIOTICS PRESCRIBED FOR 7 DAYS. THE USER HAS SINCE ADVISED THAT HE IS FEELING BETTER AND IS BACK AT WORK. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. 14-DEC-2023 - ACCORDING TO NEW INFORMATION, THE PATIENT OF THIS ADVERSE EVENT SENT A DISCHARGE LETTER TO COLOPLAST STATING THAT THEY SPENT LESS THAN 24 HOURS IN THE EMERGENCY DEPARTMENT (APPROX. 22H). DUE TO THIS NEW INFORMATION (NO PROLONGED HOSPITALIZATION) THE CASE IS NOT REPORTABLE ANYMORE.
Patient problems: Abdominal Pain; Abscess
MAUDE report 18184389 ↗
Other COLLECTOR, OSTOMY devices
- New Image 11704Hollister Incorporated · COLLECTOR, OSTOMY4 reports
- New Image 14803Hollister Incorporated · COLLECTOR, OSTOMY3 reports
- New Image 11203Hollister Incorporated · COLLECTOR, OSTOMY2 reports
- Premier 8331Hollister Incorporated · COLLECTOR, OSTOMY2 reports
- New Image 14603Hollister Incorporated · COLLECTOR, OSTOMY2 reports
- New Image 11703Hollister Incorporated · COLLECTOR, OSTOMY2 reports
- New Image 11504Hollister Incorporated · COLLECTOR, OSTOMY2 reports
- New Image 18003Hollister Incorporated · COLLECTOR, OSTOMY1 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 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.
How reports and recalls are matched · Editorial policy · Report an error on this page