MEDLINE MSC9845EPRecalls & reported problems
Medline Industries, Inc. · DRESSING, GEL FIBER, OPTICELL AG+,4X5 · Class U
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- 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 10884389717301), received between Sep 30, 2026 and Sep 30, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Degraded” (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
- Degraded1
- Material Fragmentation1
Patient problems
- Discomfort1
- Foreign Body In Patient1
- Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Degraded; Material Fragmentation
It was reported that the product "tends to deteriorate when exposed to moisture, compromising its structural integrity," "leaves behind fibers and residue in the wound bed, which may interfere with healing and require additional cleaning," and "adheres to the wound bed, often causing discomfort or pain during dressing changes."
Patient problems: Discomfort; Foreign Body In Patient; Pain
MAUDE report 50945498 ↗
Other Dressing, Wound, Drug devices
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- MediHoney® 31515Acell, Inc. · Dressing, wound, drug2 recalls6 reports
- MediHoney® 31805Acell, Inc. · Dressing, wound, drug2 recalls1 death5 reports
- MediHoney® 31535Acell, Inc. · Dressing, wound, drug2 recalls0 reports
- AQUACEL AG FOAM 420681Convatec, Purchasing Department · Dressing, Wound, Drug99 reports
- SteriCare Solutions 6240Nurse Assist, Inc. · Dressing, Wound, Drug1 recall14 reports
- Medline DYND500MLSMedline Industries, Inc. · Dressing, wound, drug1 recall5 reports
- MEDLINE MNK0005Medline Industries, Inc. · Dressing, wound, drug1 recall5 reports
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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