Comfort Short™ 100-240-01Recalls & reported problems
Unomedical A/S · Single use infusion set for subcutaneous infusion. The infusion set must be used as described in the Instruction for Use. · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 1
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05705244008458), received between Apr 18, 2018 and Apr 18, 2018 — classified as 1 death.
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.
Most reported problems
Device problems
- No Apparent Adverse Event1
Patient problems
- Death1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
DeathApr 18, 2018No Apparent Adverse Event; No Apparent Adverse Event
(B)(4). REPORTER (HCP) STATED POLICE WERE CALLED FOR A WHILE BEING CHECK. POLICE FOUND PATIENT DECEASED ON HIS BED AND HE WAS DECEASED FOR ABOUT 1-2 DAYS. REPORTER STATED THE MALE DIABETIC PATIENT WAS WEARING THE ANIMAS PUMP AT THE TIME OF DEATH AROUND HIS WAIST. REPORTER STATED PATIENT WAS BROUGHT TO THE MEDICAL EXAMINER ON (B)(6) 2018. REPORTER STATED THE AUTOPSY WAS DONE (B)(6) 2018. POLICE REPORTED THAT IT WAS HOT IN THE ROOM. BLOOD GLUCOSE LEVEL UNKNOWN AT TIME OF EVENT. REPORTER FELT DEATH OCCURRED DUE TO USE OF THE PRODUCT. NO MALFUNCTION HAS BEEN REPORTED. NO FURTHER INFORMATION AVAILABLE.
Patient problems: Death
MAUDE report 7439149 ↗
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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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