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PROCARE 79-91470Recalls & reported problems

Djo, LLC · SECURE-ALL LIMB HOLDER, 30 PR · Class 1

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 00888912038522), received between Aug 16, 2016 and Aug 16, 2016 — classified as 1 malfunction.

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

  • No Consequences Or Impact To Patient1

Recent adverse event reports

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

  • MalfunctionAug 16, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    COMPLAINT RECEIVED THAT ALLEGES " "TWO TIMES LATELY A VENTED PATIENT HAS BROKEN THE RESTRAINTS AND ONE OF THEM SELF-EXTUBATED BUT THE PATIENT WAS NOT HARMED". DEVICE NOT RETURNED TO MANUFACTURER FOR EVALUATION. NO INDICATION EVENT CAUSED OR CONTRIBUTED TO SERIOUS INJURY, PERMANENT IMPAIRMENT OR DEATH.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 5880518 ↗

Other Restraint, protective devices

All Restraint, protective devices →

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