MEDLINE MSCOVM3EPRecalls & reported problems
Medline Industries, Inc. · OPTIVIEW, MULTISITE, 3"X3" · Class 1
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 10197344155620), received between Apr 14, 2026 and Apr 14, 2026 — classified as 1 malfunction.
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
- Contact Dermatitis1
- Itching Sensation1
- Rash1
- Swelling/ Edema1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 14, 2026Patient Device Interaction Problem
ACCORDING TO THE CUSTOMER, AFTER APPLYING THE DRESSING FOR "24 HOURS" THEY DEVELOPED "ITCHING, SWELLING, AND HIVES TO THE AREA OF THE GEL CENTER".
Patient problems: Contact Dermatitis; Itching Sensation; Rash; Swelling/ Edema
MAUDE report 24874014 ↗
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- ALLEVYN LIFE L 15.4X15.4 CTN10 66801069Smith & Nephew Medical Limited · Dressing, Wound, Occlusive28 reports
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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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