Medline MDSM611505Recalls & reported problems
Medline Industries, Inc. · ELECTRODE,FOAM,MONITORING,SLD GEL,5 PK · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 8
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10884389830338), received between Sep 11, 2026 and Sep 24, 2026 — classified as 8 malfunctions.
The most frequently reported specific device problem is “Unable to Obtain Readings” (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
- Unable to Obtain Readings2
- Adhesive Too Strong1
- Adverse Event Without Identified Device or Use Problem1
- Loss of or Failure to Bond1
- Packaging Problem1
- Patient Device Interaction Problem1
- Unexpected Therapeutic Results1
Patient problems
- Burn(s)3
- Itching Sensation3
- No Clinical Signs, Symptoms or Conditions3
- Skin Tears3
- Erythema1
- Insufficient Information1
- Wheal(s)1
Recent adverse event reports
The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 24, 2026Patient Device Interaction Problem
It was reported that "Several patients have experience redness and welt formation where the electrodes were placed. Very often the redness is in the area of the surgical site."
Patient problems: Erythema; Wheal(s)
MAUDE report 50883361 ↗MalfunctionSep 21, 2026Loss of or Failure to Bond
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50840546 ↗MalfunctionSep 18, 2026Adhesive Too Strong
Patient problems: Burn(s); Itching Sensation; Skin Tears
MAUDE report 50819954 ↗MalfunctionSep 16, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Burn(s); Itching Sensation; Skin Tears
MAUDE report 50794863 ↗MalfunctionSep 16, 2026Unable to Obtain Readings
Patient problems: Insufficient Information
MAUDE report 50786560 ↗MalfunctionSep 15, 2026Unexpected Therapeutic Results
Patient problems: Burn(s); Itching Sensation; Skin Tears
MAUDE report 50780039 ↗MalfunctionSep 12, 2026Packaging Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50746336 ↗MalfunctionSep 11, 2026Unable to Obtain Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50735490 ↗
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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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