Medline MDS611505ARecalls & reported problems
Medline Industries, Inc. · ELECTRODE,FOAM,5/PK,1000/CS · Class 2
- 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 10080196320745), received between Nov 1, 2017 and Nov 1, 2017 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device Operates Differently Than Expected” (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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Device Operates Differently Than Expected1
Patient problems
- Abrasion1
- Burn(s)1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 1, 2017Device Operates Differently Than Expected
Other Electrode, electrocardiograph devices
- Vermed A10091-30Graphic Controls Acquisition Corp · Electrode, Electrocardiograph132 reports
- 3M™ 22283m Company · Electrode, electrocardiograph2 recalls0 reports
- 3M™ Red Dot™ 22283m Company · Electrode, electrocardiograph1 recall4 reports
- Vital Signs™ 2464AAO-20AirLife Finland Oy · Electrode, electrocardiograph51 reports
- Vermed IP-Set M5 RT Adult-USGraphic Controls Acquisition Corp · Electrode, Electrocardiograph1 recall0 reports
- Vermed IP-Set 12 RT Adult-USGraphic Controls Acquisition Corp · Electrode, Electrocardiograph1 recall0 reports
- Vermed IP-Set N3-Pediatric-USGraphic Controls Acquisition Corp · Electrode, Electrocardiograph1 recall0 reports
- Vermed IP-Set M3 RT Adult-USGraphic Controls Acquisition Corp · Electrode, Electrocardiograph1 recall0 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.