POSEY 2795Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10190676002747), received between Apr 19, 2023 and Nov 14, 2023 — classified as 2 malfunctions.

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

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 14, 2023Break; Break

  CUSTOMER IS REPORTING A COMPLAINT ON PRODUCT # 2795, LOT # 3143T059. CUSTOMER STATES THAT A PATIENT WAS ABLE TO REMOVE HERSELF FROM HER RESTRAINT BECAUSE THE VELCRO RIPPED OFF THE CUFF. PRODUCT HAS ONLY BEEN WASHED TWICE. PICTURES HAVE BEEN SENT TO QUALITY. A RN WAS ASSAULTED BUT NOT INJURED AS A RESULT. ADVISE TECH SERV ONCE THE INSPECTION HAS BEEN COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18132090 ↗
• 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 16773640 ↗