VitalPatch® RTM 4007-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00850490007450), received between Aug 30, 2021 and Aug 30, 2021 — classified as 1 injury.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (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

Recent adverse event reports

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

• InjuryAug 30, 2021Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  THIS IS A (B)(6) CAUCASIAN FEMALE WHO DECLINED TO SHARE HER FULL MEDICAL HISTORY WITH A VITALCONNECT NURSE, BUT DID DISCLOSE THE FOLLOWING KNOWN ALLERGIES: MEDICATION ALLERGIES: AUGMENTIN AND PROZAC ENVIRONMENTAL/ FOOD ALLERGIES: WHEAT, PEANUTS, HORSES AND CATS (CAUSES WELTS AND BLISTERS WITH EXPOSURE). SHE DENIES SENSITIVITY TO LATEX OR ADHESIVES PRIOR TO THIS EVENT. ON (B)(6) 20201, A VITALCONNECT REPRESENTATIVE RECEIVED A REPORT OF SKIN IRRITATION ON A (B)(6)CAUCASIAN FEMALE FROM A CARDIOLOGIST AT A HEART CLINICAL IN (B)(6). THE PATIENT HAD GIVEN PERMISSION FOR A VITALCONNECT REPRESENTATIVE TO CONTACT HER DIRECTLY. A PHONE CALL WAS PLACED TO THE PATIENT BY A VITALCONNECT NURSE AND THE PATIENT RETURNED THE CALL ON (B)(6) 2021. DURING THE CALL, THE PATIENT STATED THAT SHE HAD AN APPOINTMENT ON (B)(6) WITH HER CARDIOLOGIST AT THE CARDIOLOGY FACILITY WHERE SHE WAS PATCHED WITH THE VITALCONNECT VITALPATCH FOR A 28 DAY STUDY. SHE REPORTS THAT HER CARDIOLOGIST INFORMED HER THAT VITALCONNECT WAS A NEW COMPANY AND HE WANTED TO TRY THIS NEW PATCH ON HER BECAUSE OF ITS VERSATILITY. SHE ALSO REPORTS THAT SHE WAS GIVEN INSTRUCTIONS THAT SHE COULD SHOWER, EXERCISE, AND SWIM IN THE PATCH AS LO

  Patient problems: Contact Dermatitis

  MAUDE report 12388721 ↗