Wings 66034Recalls & reported problems
Cardinal Health, Inc. · Adult Quilted Briefs,Heavy · Class 1
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20884527000682), received between Dec 22, 2021 and Dec 22, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Gel Leak” (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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Gel Leak1
Patient problems
- Discomfort1
- 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.
MalfunctionDec 22, 2021Gel Leak; Gel Leak
THE CUSTOMER REPORTED THAT THE POLYMER BEADS WERE OUTSIDE THE FLUFF LAYER OF THE BRIEF, COMING IN CONTACT WITH THE SKIN AND CAUSING DISCOMFORT AND IRRITATION FOR THE PATIENTS.
Patient problems: Discomfort; Skin Inflammation/ Irritation
MAUDE report 13061947 ↗
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.