POSEY 2798Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10190676002709), received between Feb 20, 2023 and Feb 27, 2026 — classified as 7 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 27, 2026Difficult to Open or Close

  SUPPLEMENTAL MEDWATCH BEING SENT FOR ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24469132 ↗
• 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 24469093 ↗
• MalfunctionApr 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CUSTOMER REPORTING A COMPLAINT ON PRODUCT # 2799 & 2798. CUSTOMER STATES THEY HAVE HAD ONGOING ISSUES WITH THE RESTRAINTS BUCKLING AFTER BEING WASHED. AN RN GOT A SPRAINED HAND TRYING TO CLOSE THE BUCKLE ON A SET SHE WAS USING.

  Patient problems: Damage to Ligament(s)

  MAUDE report 19082621 ↗
• MalfunctionMar 25, 2024Mechanical Problem; Mechanical Problem

  CUSTOMER REPORTING A COMPLAINT ON PRODUCT # 2798 LOT#3305T029 RESTRAINT. A STAFF MEMBER WAS INJURED TRYING TO CLOSE THE 2798 RESTRAINT. WHICH RESULTED IN THE STAFF MEMBER HAVING TO MISS TIME FROM WORK. THIS INCIDENT OCCURED SEVERAL WEEKS AGO AND THE CUSTOMER DOES NOT HAVE THE ORIGINAL PRODUCT THAT WAS INVOLVED IN THE INCIDENT.

  Patient problems: Insufficient Information

  MAUDE report 18970874 ↗
• 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 18416572 ↗
• MalfunctionOct 12, 2023Break; Break

  CUSTOMER IS REPORTING A COMPLAINT ON PRODUCT # 2798 RESTRAINT. CUSTOMER STATES THAT THE STRAP BROKE FREE OF THE BOX STITCHING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17922930 ↗
• MalfunctionFeb 20, 2023Break; Break

  TM REPORTED COMPLAINT VIA EMAIL. TWO RESTRAINT SKUS 2798 AND 2799 HAD TEARING FROM THE STRAP, IN THE SEWEN AREA. AN INCIDENT OCCURRED ON (B)(6) 2023, STAFF MEMEBER WAS INJURED. NO LOT NUMBER WAS LOCATED ON EITHER PRODUCT, CUSTOMER STATES THEY'VE BEEN USING THESE PRODUCTS FOR AT LEAST TWO YEARS. REQUEST TO HAVE PRODUCT RETURNED FOR QA EVALUATION.

  Patient problems: Insufficient Information

  MAUDE report 16405003 ↗