POSEY 2793Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10190676002723), received between Sep 9, 2022 and Jul 18, 2024 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Break” (2 reports).

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

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 18, 2024Break; Break

  PER THE CUSTOMER: PATIENT WAS IN MECHANICAL RESTRAINTS TODAY, THE LOWER LIMB RESTRAINT COMPLETELY BROKE WHICH RELEASED THE LIMB. LOT #1181T090; SKU 2793. NO INCIDENT OR INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19774621 ↗
• 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 16773619 ↗
• MalfunctionNov 8, 2022Break; Break

  THE CUSTOMER WOULD LIKE TO RETURN PRODUCT FOR INSPECTION AND REPORT. THE CUSTOMER STATES THAT THEIR RESTRAINTS 2793 FAILED. CUSTOMER STATES THAT PATIENTS WERE ABLE TO CAUSE THE RESTRAINTS TO TEAR AWAY AT THE BOX SEAM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15754288 ↗
• MalfunctionSep 9, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  THE CUSTOMER CONTACTED US VIA E-MAIL. THE CUSTOMER STATES THAT THEY HAVE A 2793 THAT RIPPED AT THE SEAMS. THE PATIENT WAS ACTIVE/COMBATIVE. THE CUSTOMER STATES THIS IS THE 2ND PAIR THAT TORE AT THE SEAMS. CUSTOMER STATES THEY HAVE THE ORIGINAL PRODUCT TO RETURN. NO LOT# OR GTIN INFORMATION WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15396384 ↗