POSEY 2550Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10190676004932), received between May 2, 2025 and May 2, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Slipped” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 2, 2025Device Slipped; Device Slipped

  CUSTOMER REPORTED: I AM THE CLINICAL NURSE LEADER IN THE (B)(6) ICU. I WANTED TO GET YOUR INSIGHT INTO A CONCERN THAT I HAVE WITH OUR CURRENT WRIST RESTRAINTS. WE RECENTLY HAD A PATIENT THAT WAS ABLE TO SELF-EXTUBATE DUE TO LOOSENING OF HIS BILATERAL WRIST RESTRAINTS. HE WAS ABLE TO DEMONSTRATE HOW HE WAS ABLE TO GET OUT OF THEM AND AFTER MORE INVESTIGATION I FOUND THAT IT REALLY WAS NOT DIFFICULT TO GET OUT OF MULTIPLE PAIRS OF WRIST RESTRAINTS. I AM WONDERING IF HAVING THEM LAUNDERED FREQUENTLY IS LOOSENING THE BUCKLE AND IMPACTING THE VELCRO. IS THIS SOMETHING THAT OTHER ORGANIZATIONS HAVE BEEN REPORTING? IS THERE A RECOMMENDATION FOR HOW MANY TIMES THE RESTRAINTS SHOULD BE WASHED BEFORE THEY NEED TO BE REPLACED? DO YOU HAVE ANY THOUGHTS OR RECOMMENDATIONS REGARDING HOW TO MOVE FORWARD? I WOULD THINK THAT THEY WOULD BE ABLE TO BE WASHED AT LEAST A FEW TIMES BEFORE THE MATERIAL BEGINS TO BREAKDOWN. I AGREE THAT THE RESTRAINTS SHOULD HAVE A VISUAL INSPECTION BEFORE USE, BUT THE LOOSENING ON THE STRAP IS NOT SOMETHING THAT YOU WOULD CATCH ON VISUAL.

  Patient problems: Unintended Extubation

  MAUDE report 21950335 ↗