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POSEY 2794Recalls & reported problems

Posey Products, LLC · POSEY TWICE AS TOUGH · 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 10190676002730), received between Apr 19, 2023 and Apr 19, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Mechanical 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

  • Mechanical Problem1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

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

  • MalfunctionApr 19, 2023Mechanical Problem; Mechanical Problem

    CUSTOMER REPORTS A COMPLAINT ON PRODUCT # 2792, 2793, 2794, & 2795. CUSTOMER STATES THAT PATIENTS ARE ABLE TO GET OUT OF THE RESTRAINT CUFFS. STAFF WAS ABLE TO DEMOSTRATE THAT THE D-RING WAS ABLE TO FIT INSIDE ITSELF AND RELEASE. STAFF REPORTED THAT THIS CAN HAPPEN WHEN THEY TIGHTEN THE RESTRAINT AND THE PATIENT CAN ALSO RELEASE THE RESTRAINT WITH THEIR TEETH. LOT# 2792 - 1251T055, 2794 - 2228T047, & 2793 - 2083T023 & 2220T109.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16773621 ↗

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.