Medline MDSM611550Recalls & reported problems
Medline Industries, Inc. · ELECTRODE, FOAM, 50PK · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 20884389830342), received between Jun 16, 2024 and Sep 23, 2026 — classified as 2 injuries, 1 malfunction.
The most frequently reported specific device problem is “Biocompatibility” (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
- Biocompatibility2
- Patient Device Interaction Problem2
- Patient-Device Incompatibility1
Patient problems
- Blister2
- Hypersensitivity/Allergic reaction1
- Rash1
- Skin Burning Sensation1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 23, 2026Biocompatibility
Patient problems: Blister; Rash; Skin Burning Sensation
MAUDE report 50872819 ↗InjuryMar 4, 2026Patient-Device Incompatibility; Biocompatibility; Patient Device Interaction Problem
ACCORDING TO THE CUSTOMER PHONE CALL, SHE HAD GONE TO THE HOSPITAL ON (B)(6) 2025 AND THEY PLACED MEDLINE ELECTRODES ON HER. THAT CAUSED A SKIN REACTION, BURNING, AND ITCHING TO THE SKIN.
Patient problems: Hypersensitivity/Allergic reaction
MAUDE report 24506790 ↗InjuryJun 16, 2024Patient Device Interaction Problem; Patient Device Interaction Problem
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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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