Medline Industries, Inc. DYNJ54723ARecalls & reported problems
Medline Industries, Inc. · EYE MUSCLE · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10195327020415), received between Apr 21, 2026 and Apr 21, 2026 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Material Frayed” (3 reports).
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
- Material Frayed3
- Material Integrity Problem3
Patient problems
- Foreign Body In Patient3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 21, 2026Material Frayed; Material Integrity Problem
ACCORDING TO THE FACILITY ON (B)(6) 2026, THE "QTIPS (LISTED IN THE PACK AS COTTON TIP APPLICATOR WERE USED FROM PACK) - NOTED TO HAVE FRAYING FIBERS ON SOME OF THE APPLICATORS. SOME WERE WORSE THAN OTHERS, BUT FIBERS WERE COMING OFF OF THE APPLICATOR WHEN USED IN THE SURGICAL SITE (EYE) AND REQUIRING THE SURGEON TO PULL THESE FROM THE SURGICAL SITE.
Patient problems: Foreign Body In Patient
MAUDE report 24947729 ↗MalfunctionApr 21, 2026Material Frayed; Material Integrity Problem
ACCORDING TO THE FACILITY ON (B)(6) 2026, THE "QTIPS (LISTED IN THE PACK AS COTTON TIP APPLICATOR WERE USED FROM PACK) - NOTED TO HAVE FRAYING FIBERS ON SOME OF THE APPLICATORS. SOME WERE WORSE THAN OTHERS, BUT FIBERS WERE COMING OFF OF THE APPLICATOR WHEN USED IN THE SURGICAL SITE (EYE) AND REQUIRING THE SURGEON TO PULL THESE FROM THE SURGICAL SITE. NO HARM OCCURRED.
Patient problems: Foreign Body In Patient
MAUDE report 24941577 ↗MalfunctionApr 21, 2026Material Frayed; Material Integrity Problem
ACCORDING TO THE FACILITY ON 3/23/2026, THE "QTIPS" (LISTED IN THE PACK AS COTTON TIP APPLICATOR WERE USED FROM PACK) - NOTED TO HAVE FRAYING FIBERS ON SOME OF THE APPLICATORS. SOME WERE WORSE THAN OTHERS, BUT FIBERS WERE COMING OFF OF THE APPLICATOR WHEN USED IN THE SURGICAL SITE (EYE) AND REQUIRING THE SURGEON TO PULL THESE FROM THE SURGICAL SITE.
Patient problems: Foreign Body In Patient
MAUDE report 24940251 ↗
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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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