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CHATTANOOGA 4759Recalls & reported problems

Djo, LLC · TX TRACTION UNIT PKG · 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 00888912023825), received between Apr 29, 2019 and Apr 29, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (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 Interaction Problem1
  • Unintended Movement1

Patient problems

  • No Known Impact Or Consequence To Patient1
  • Pressure Sore/Ulcer1

Recent adverse event reports

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

  • MalfunctionApr 29, 2019Unintended Movement; Patient Device Interaction Problem; Unintended Movement; Patient Device Interaction Problem

    IT WAS REPORTED THAT "IT IS HAVING AN INTERMITTENT ISSUE... WHEN THE UNIT HAS BEEN SITTING IDLE WITH THE ROPE OUT AND THEY GO TO REMOVE ALL OF THE SLACK ONCE ATTACHED TO THE PATIENT, THEY PRESS THE ROPE RELEASE AND IT VIOLENTLY SNAPS BACK WITH FORCE AND A LOUD NOISE. THEN THE ROPE RELEASE WILL OPERATE NORMALLY AGAIN IN AND OUT UNTIL IT HAS BEEN SITTING IDLE AGAIN FOR SOME TIME." THERE WAS NO REPORTED PATIENT HARM.

    Patient problems: No Known Impact Or Consequence To Patient; Pressure Sore/Ulcer

    MAUDE report 8562142 ↗

Other EQUIPMENT, TRACTION, POWERED devices

All EQUIPMENT, TRACTION, POWERED devices →

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