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Kendall 30807732 (UDI 20884527002723)Recalls & reported problems

Cardinal Health, Inc. · 5500 Diagnostic Tab Electrodes · Class 2

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20884527002723), received between Jun 25, 2019 and Jun 25, 2019 — classified as 1 injury.

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

  • Adverse Event Without Identified Device or Use Problem1

Patient problems

  • Skin Tears1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryJun 25, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    CUSTOMER REPORTS: DURING AN OPHTHALMOLOGICAL EXAMINATION, THE PATIENT HAD TO HAVE THE DIAGNOSTIC PATCHES GLUED TO THE FACE. AFTER THE EXAMINATION WHEN THE PATCHES WERE REMOVED ONE OF THE PATCHES RIPPED THE SKIN OFF THE PATIENT'S FACE. THE CURRENT STATUS OF THE PATIENT IS AN OPEN WOUND AND 5 STITCHES. PER ADDITIONAL INFORMATION RECEIVED ON 24JUN2019, THE PATIENT IS A (B)(6) YR OLD MALE, DOB (B)(6). NO RECENT MEASUREMENT OF WEIGHT. MEDICAL HISTORY NOT AVAILABLE. RACE NOT AVAILABLE. THE ELECTRODES WERE PLACED ON THE PATIENT¿S FACE DURING AN ELECTRORETINOGRAM. IT IS UNKNOWN WHICH MACHINE WAS USED. THE DURATION OF THE PROCEDURE (EXAMINATION TIME) AND HOW LONG THE ELECTRODES WERE ON THE PATIENT'S FACE IS UNKNOWN.

    Patient problems: Skin Tears

    MAUDE report 8732591 ↗

Other Electrode, electrocardiograph devices

All Electrode, electrocardiograph devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.