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Vermed A10091-5Recalls & reported problems

Graphic Controls Acquisition Corp · 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 70813150021615), received between May 25, 2018 and May 25, 2018 — classified as 1 injury.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (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

  • Patient-Device Incompatibility1

Patient problems

  • Burning Sensation1
  • Discomfort1
  • Erythema1
  • Hemorrhage/Blood Loss/Bleeding1
  • Pain1
  • Reaction1

Recent adverse event reports

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

  • InjuryMay 25, 2018Patient-Device Incompatibility

    MY CARDIOLOGIST PRESCRIBED THE "CARDIOKEY EXTENDED HOLTER MONITORING" DEVICE FOR ME. I BEGAN WEARING IT ON (B)(6) 2018, AND WAS INSTRUCTED TO WEAR IT CONTINUOUSLY FOR 14 DAYS, CHANGING THE ELECTRODE PATCHES EVERY OTHER DAY. I HAD TOLD THE NURSE WHO GAVE ME INSTRUCTIONS ON USING THE DEVICE THAT I HAD HAD SKIN REACTIONS TO WEARING PATCHES IN THE PAST, AND THAT I WAS VERY CONCERNED ABOUT WEARING THE ADHESIVE-COATED ELECTRODES FOR 2 WEEKS, PUTTING THEM BACK IN THE SAME PLACE ON MY CHEST EVERY TIME THEY WERE CHANGED. I WAS REASSURED THAT THE "HOLTER" WAS "HYPOALLERGENIC" AND WOULD "NOT BE A PROBLEM." BY (B)(6) 2018, AFTER WEARING THE ELECTRODES FOR 7 DAYS, MY SKIN HAD DEVELOPED BLISTERS UNDER THE ELECTRODES. BY (B)(6) 2018, THOSE BLISTERS HAD STARTED WEEPING. BECAUSE IT HAD BEEN STRONGLY EMPHASIZED THAT THE INFORMATION GAINED FROM THE "HOLTER" WAS "VERY IMPORTANT TO [MY] HEALTH," I CONTINUED TO WEAR THE DEVICE IN SPITE OF THE CONSTANT BURNING PAIN. AT THE END OF THE 2-WEEK PERIOD, THE TWO PLACES ON MY CHEST WHERE THE ELECTRODES HAD BEEN WERE BRIGHT RED, BLISTERED, AND IN ONE CASE, ACTUALLY BLEEDING. NOT MY CARDIOLOGIST, HIS NURSE, NOR THE COMPANY PRODUCING THE "HOLTER" GAVE ME ANY INDIC

    Patient problems: Burning Sensation; Discomfort; Erythema; Hemorrhage/Blood Loss/Bleeding; Pain; Reaction

    MAUDE report 7549044 ↗

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