POSEY 2799Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10190676002693), received between Oct 12, 2022 and Feb 27, 2026 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 27, 2026Difficult to Open or Close

  CUSTOMER IS REPORTING A COMPLAINT ON THE PRODUCTS 2799 AND 2798 LOT# 3081T146 4254T193 & 4240T421. CUSTOMER STATES THAT THREE DIFFERENT RESTRAINTS MALFUNCTIONED AND WOULD NOT LOCK AS THEY WERE INTENDED TO. THEY HAD TO USE A HARD RESTRAINT AS A RESULT. INJURY WAS INVOLVED IN THE PATIENT INCIDENT BUT NO DETAILS ON NATURE OF THE INJURY. CUSTOMER NOTES THE ONLY WAY THEY COULD GET THE RESTRAINT TO LOCK WAS WITH A MULTI-TOOL FROM SECURITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24468834 ↗
• MalfunctionJun 18, 2024Difficult to Open or Close; Difficult to Open or Close

  LIMITED INFORMATION PROVIDED. NO PURCHASE DATE OR LOT# PROVIDED FOR AGE. PER THE TM, ITEM 2799 LOCK COULD NOT BE CLOSED PROPERLY DURING APPLICATION. THE ISSUE MAY HAVE RESULTED IN A MINOR INJURY WITH THE CAREGIVER.

  Patient problems: Insufficient Information

  MAUDE report 19563515 ↗
• MalfunctionJan 19, 2024Break; Break

  CUSTOMER REPORTING COMPLAINT ON PRODUCT # 2799. CUSTOMER STATES THAT THE RESTRAINT WAS IN USE FOR 2 HOURS AND THE BOX SEAMS RIPPED OFF THE STRAP. NO INJURIES/DEATH AS RESULT OF PATIENT INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18547815 ↗
• MalfunctionDec 29, 2023Mechanical Problem; Mechanical Problem

  CUSTOMER IS REPORTING COMPLAINT ON PRODUCT # 2798 & 2799. CUSTOMER STATES THAT PRODUCT # 2798 & 2799 HAS BECOME INCREASINGLY DIFFICULT TO LOCK THE RESTRAINT ONCE IT HAS RETURNED FROM BEING LAUNDERED. THIS HAS LED TO INJURIES TO BOTH STAFF & PATIENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18417023 ↗
• MalfunctionSep 28, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  CUSTOMER IS REPORTING A COMPLAINT ON PRODUCT # 2799 WITHA LOT# 3034T048 PRODUCT. THE FOAM RIPPED AWAY FROM THE LOCKED RESTRAINT STRAP. THIS ALLOWED THE PATIENT TO GET OUT OF THE RESTRAINTS, NO INJURIES TO PATIENT OR STAFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17840098 ↗
• MalfunctionJun 14, 2023Break; Break

  CUSTOMER FILING A COMPLAINT ON PRODUCT # 2799 LOT# 2263T033. (B)(6) CUSTOMER IS STATING THE STICHING FAILED ON THE PRODUCT # 2799. THE DATE THE ISSUE WAS DISCOVERED IS UNKNOWN AND NO PATIENT INCIDENT OR INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17126748 ↗
• MalfunctionApr 19, 2023Break; Break

  CUSTOMER IS REPORTING A COMPLAINT ON PRODUCT # 2799. DEAN ROBERTS TM 386-747-0989 OR E-MAIL [email protected]. CUSTOMER STATES THAT THE BOX STITCH FAILED RESULTING IN THE PATIENT BEING ABLE TO GET FREE OF THE RESTRAINT. NO REPORTED INJURY/DEATHS FROM THE INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16773643 ↗
• MalfunctionFeb 20, 2023Break; Break

  SUPPLEMENTAL MEDWATCH BEING SENT FOR ADDITIONAL INFORMATION.

  Patient problems: Insufficient Information

  MAUDE report 16405360 ↗
• MalfunctionOct 12, 2022Break; Break

  CUSTOMER CONTACTED US IN REGARDS TO A SERIES OF 2799 RESTRAINTS FAILING AT THE BOX STITCH. THE CUSTOMER SAYS THEY HAVE HAD FOUR INCIDENTS NOW. THEY ARE UNSURE IF THEY ARE ALL RELATED TO 2799 OR IF SOME WERE 2798. RNS COULD NOT REMEMBER IF THEY WERE RED OR BLUE. CUSTOMER DOES HAVE AN EXAMPLE THAT WAS SAVED. LOT# 2167T011 IS FROM THE RESTRAINT THAT BROKE. CUSTOMER STATES THAT IT WAS A WOMAN WHO BROKE THE RESTRAINT. SHE WAS IN A VERY AGITATED AND COMBATIVE STATE FROM WHAT THE CUSTOMER STATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15588647 ↗