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CHATTANOOGA 59005Recalls & reported problems

Djo, LLC · ELECTRODES VITALSTIM SMALL 12 PACK · 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 00888912357074), received between Sep 16, 2021 and Sep 16, 2021 — 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

  • Local Reaction1

Recent adverse event reports

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

  • InjurySep 16, 2021Patient-Device Incompatibility

    IT WAS REPORTED THAT THE PATIENT ALLEGEDLY EXPERIENCED A REACTION (REDNESS ON SKIN) FROM EITHER THE GEL ON THE ACTUAL ELECTRODE OR THE ADHESIVE AROUND THE ELECTRODE.

    Patient problems: Local Reaction

    MAUDE report 12484941 ↗

Other ELECTRODE, CUTANEOUS devices

All ELECTRODE, CUTANEOUS devices →

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