Skip to content

CHATTANOOGA 27383Recalls & reported problems

Djo, LLC · ULTRASOUND APPLICATOR, 5 CM, GRAY · 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 00888912021906), received between Feb 5, 2020 and Feb 5, 2020 — classified as 1 injury.

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 Problem1

Patient problems

  • Burn(s)1

Recent adverse event reports

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

  • InjuryFeb 5, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT "DURING PATIENT VISIT E-STIM MACHINE USED ON PATIENT. WHEN PATIENT WENT HOME SHE NOTICED 4 DISTINCT BURN MARKS ON HER BACK WHERE THE E-STIM PADS HAD BEEN PLACED. PATIENT WENT TO URGENT CARE WHERE SHE WAS DX WITH PARTIAL THICKNESS BURNS AND SILVADENE DRESSING PLACED ALONG WITH ORDER TO FOLLOW UP WITH HER PCP (PRIMARY CARE PHYSICIAN) AND WOUND CARE CLINIC."

    Patient problems: Burn(s)

    MAUDE report 9670740 ↗

Other Ultrasonic diathermy for use in applying therapeutic deep heat devices

All Ultrasonic diathermy for use in applying therapeutic deep heat devices →

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