Medline MDSM611850RRecalls & reported problems
Medline Industries, Inc. · ELECTRODE,RADIOTRANSLUCENT,FOAM,50PK · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10884389830437), received between Sep 16, 2026 and Sep 21, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Adhesive Too Strong” (2 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
- Adhesive Too Strong2
Patient problems
- Skin Tears2
- Bruise/Contusion1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 21, 2026Adhesive Too Strong
It was reported that "Since they started sending us the ones with red on the packaging (its been months), we've had two significant skin tears, several complaints about bruising or skin issues at the electrode site during post-procedure phone calls, and in recovery every day we have people who have residual gluey paper that doesn't come off with the electrode that has to be scrubbed off with alcohol and its very difficult to get off."
Patient problems: Bruise/Contusion; Skin Tears
MAUDE report 50841719 ↗MalfunctionSep 16, 2026Adhesive Too Strong
Patient problems: Skin Tears
MAUDE report 50790569 ↗
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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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