POSEY 2631Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10190676005366), received between Oct 20, 2023 and Apr 22, 2025 — classified as 2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 22, 2025Break; Break

  CUSTOMER REPORTED A RESTRAINT TEAR WHILE ON THE PATIENT. THE PATIENT WAS PULLING VERY HARD ON THE RESTRAINTS AND THEY RIPPED. PART 2631. THE EVENT HAPPENED ON (B)(6) BUT WAS REPORTED TO TIDI ON (B)(6) 2025. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21878848 ↗
• MalfunctionOct 20, 2023Break; Break

  A POSEY LIMB HOLDER MADE OF COTTON/FLANNEL-LINED WAS IN USE ON A BED TO PROTECT THE PATIENT FROM SELF-HARM. THE PATIENT WAS EXTREMELY RESTLESS AND WAS ABLE TO PULL FREE FROM THE DEVICE. THE PATIENT WAS NOT HARMED AND WAS UNABLE TO HARM HIMSELF. UPON CLOSER INSPECTION OF THE WRIST RESTRAINT, IT WAS APPARENT THAT THE FIBERS WERE FRAYED AND APPEARED TO BECOME UNWRAPPED. IT DETACHED BETWEEN THE BASE OF THE TRIANGLE SHAPED WRIST WRAP AND THE ACTUAL STRAP, LESS THAN ONE INCH FROM THE POINT OF ATTACHMENT. THE TEAR OCCURRED ON THE STRAP ITSELF. IT DID NOT COME UNSEWN, NOR DID IT PULL FREE FROM THE WRAP. THE POINT OF FAILURE WAS ON THE STRAP ITSELF. THE PATIENT WAS ABLE TO RIP IT SIMPLY FROM HIS EFFORTS TO BREAK FREE FROM THE WRIST RESTRAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17978286 ↗