DeRoyal 46-IV22Recalls & reported problems
Deroyal Industries, Inc. · Algidex Ag IV Catheter Patch5B 10C · Class U
Data updated Oct 16, 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 00749756590228), received between Jul 30, 2026 and Jul 30, 2026 — classified as 1 injury.
The most frequently reported specific device problem is “Patient Device Interaction 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.
Reports received per month
Most reported problems
Device problems
- Patient Device Interaction Problem1
Patient problems
- Purulent Discharge1
- Rash1
- Skin Inflammation/ Irritation1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJul 30, 2026Patient Device Interaction Problem
An end consumer reported through a MedWatch, ""[Site]" redness "[Catheter site redness]"Oozing brown liquid that dries hard around brand IV Remodulin centralline exit site; ongoing irritation and discharge around central line exit area, brownish-gold discharge "[Catheter site discharge]" Ongoing irritation and discharge around central line exit area "[Catheter site irritation]" Ongoing irritation and discharge around central line exit area despite trying Algidex antimircrobial disc and switching to iodine and alcohol dressing "[No therapeutic response]" Not been using antimicrobial disc, nor stabilization device and using wash cloths with Cerave to clean skin around exit site "[Device use issue]"." Within this complaint the DeRoyal part was listed as a co-suspect in the report.
Patient problems: Purulent Discharge; Rash; Skin Inflammation/ Irritation
MAUDE report 50090501 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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