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BodyGuardian SP1007Recalls & reported problems

Preventice Technologies, Inc. · Strip - Silicone 1007 · 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 00852132007026), received between Oct 11, 2017 and Oct 11, 2017 — 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

  • Reaction1
  • Skin Inflammation1

Recent adverse event reports

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

  • InjuryOct 11, 2017Patient-Device Incompatibility

    APPLIED THE BODYGUARDIAN STRIP (STRIP - SILICONE 1007) FOR CARDIAC HEART MONITOR VERTICALLY TO LEFT OF STERNUM. NEXT DAY, I HAD LARGE WELTS WHERE THE 4 METAL SNAPS WERE RESTING AGAINST MY SKIN. I SUSPECT THESE SNAPS ARE MADE OF NICKEL WHICH I HAD A REACTION TO THIS METAL SOME 30 YEARS AGO. I TRIED TO APPLY IT THE NEXT DAY IN THE HORIZONTAL IN AN AREA NOT AFFECTED THE FIRST DAY AND THE SAME THING HAPPENED AFTER 24 HOURS AT THE NEW LOCATION.

    Patient problems: Reaction; Skin Inflammation

    MAUDE report 6940262 ↗

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.