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VitalPatch® Active Biosensor 3012-01Recalls & reported problems

Vital Connect, Inc. · Class 2

Adverse event reports
2
Deaths reported
0
Injuries reported
2
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00850490007146), received between Sep 22, 2017 and Sep 27, 2017 — classified as 2 injuries.

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 Problem2

Patient problems

  • Ulceration2

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • InjurySep 27, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    SUBJECT HAD APPLIED THE DEVICE ON (B)(6) 2017 AND IN THE EVENING STARTED HAVING A BURNING SENSATION, IRRITATING THE SKIN A LITTLE BIT. THE SYMPTOMS WENT AWAY. UPON REMOVAL ON (B)(6) 2017, THE SUBJECT NOTICED THAT THE AREA UNDER THE BATTERY SIDE WAS RAW AND HAD BROKEN SKIN. THE PATIENT DID NOT SEEK MEDICAL ATTENTION FOR THIS SKIN ULCERATION; THE SITUATION RESOLVED ON ITS OWN.

    Patient problems: Ulceration

    MAUDE report 6898653 ↗
  • InjurySep 22, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    SUBJECT HAD APPLIED THE DEVICE ON (B)(6) 2017 AND REPORTED EXPERIENCING A BURNING SENSATION, WHICH WENT AWAY (B)(6) 2017. A STINGING SENSATION REMAINED UNTIL THE DEVICE WAS REMOVED, USING ADHESIVE REMOVER, ON (B)(6) 2017. AT THAT TIME, THE SUBJECT'S DAUGHTER INDICATED THAT "IT'S SUPER RED AND HAS A HOLE IN HER CHEST" AND THAT THE SKIN WAS BROKEN. A SECOND DEVICE WAS APPLIED ON (B)(6) 2017 JUST BELOW THE ORIGINAL POSITION, NOT TOUCHING THE OPEN WOUND. THE 2ND PATCH WAS REMOVED BY A NURSE ON (B)(6) 2017; THERE WAS A MILD REDNESS AND IRRITATION UNDER THE LOCATION WHERE THE SECOND DEVICE HAD BEEN LOCATED. THE SUBJECT AGREED TO WEAR A THIRD DEVICE. THE SUBJECT SAW THE PRIMARY INVESTIGATOR, WHO DIAGNOSED THE PATIENT WITH SKIN ULCERATION OF THE LEFT CHEST. THE WOUND MEASURED 1 CM IN DIAMETER, AND THE SUBJECT WAS PRESCRIBED ORAL ANTIBIOTICS.

    Patient problems: Ulceration

    MAUDE report 6889006 ↗

Other Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) devices

All Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) devices →

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