Medline MDSM611803RRecalls & reported problems
Medline Industries, Inc. · ELECTRODE,RADIOTRANSLUCENT,FOAM,3PK · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10884389830413), received between Aug 10, 2023 and Sep 14, 2026 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Connection 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Appropriate Device Problem Term/Code Not Available1
- Connection Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- Skin Inflammation/ Irritation1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 14, 2026Connection Problem
It was reported that the electrodes have been mis-firing.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50754439 ↗InjuryAug 10, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
ACCORDING TO THE CUSTOMER, HER SON HAD THE ELECTRODES APPLIED FOR A "SLEEP STUDY" AND UPON REMOVING THE ELECTRODES HE HAD "RED MARKS THAT WERE RAISED, UNCOMFORTABLE, AND ITCHY".
Patient problems: Skin Inflammation/ Irritation
MAUDE report 17501920 ↗
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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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