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COMPEX 11-2137Recalls & reported problems

Djo, LLC · SPORT ELITE · Class 2

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888912000260), received between Oct 5, 2018 and Oct 5, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Fire” (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

  • Fire1

Patient problems

  • No Patient Involvement1

Recent adverse event reports

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

  • MalfunctionOct 5, 2018Fire; Fire

    IT WAS REPORTED THAT THERE WAS A SHORTAGE IN THE COMPEX DEVICE THAT CAUSED IT TO CATCH FIRE AND SPREAD TO THE END USER'S KITCHEN TABLE. THE DEVICE WAS STORED IN THE BOX IT CAME IN WITH THE PADS AND INSTRUCTIONAL PAPER ON TOP OF THE END USER'S KITCHEN TABLE. THE DEVICE WAS CHARGED BEFOREHAND, BUT IT WAS DISCONNECTED WHILE IN THE BOX. NOTHING WAS BURNED BESIDES THE KITCHEN TABLE, BUT A LOT OF SMOKE SPREAD THROUGHOUT THE HOUSE. NO ONE WAS AT THE HOUSE DURING THE ACCIDENT EXCEPT FOR THE END USER'S DOG, WHOM A VETERINARIAN CONFIRMED WAS UNHARMED. FIREFIGHTERS WERE CALLED TO THE SCENE TO EXTINGUISH THE FIRE. THE INVOLVED FIRE DEPARTMENT IS REPORTEDLY UNABLE TO RETURN THE DEVICE.

    Patient problems: No Patient Involvement

    MAUDE report 7939691 ↗

Other STIMULATOR, MUSCLE, POWERED, FOR MUSCLE CONDITIONING devices

All STIMULATOR, MUSCLE, POWERED, FOR MUSCLE CONDITIONING devices →

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