POSEY 2510Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10190676005298), received between Aug 18, 2022 and Aug 23, 2024 — classified as 1 death, 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (4 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryAug 23, 2024Break; Break

  COMPLAINTS REPORTED PATIENT TORE THE TIES OFF THE RESTRAINT WITH BRUTE FORCE. THE PATIENT WAS ABLE TO SELF EXTUBATE. RESULTED IN PATIENT HARM.

  Patient problems: Insufficient Information

  MAUDE report 20057300 ↗
• MalfunctionAug 23, 2024Break; Break

  COMPLAINTS REPORTED ECONOMY LIMB HOLDER SEPARATED AT THE POINT WHERE THE TIEDOWN CONNECTS TO THE SOFT WRIST RESTRAINT. NYLON RIPPED EASILY FROM SOFT LIMB RESTRAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20055282 ↗
• InjuryAug 23, 2024Break; Break

  COMPLAINTS REPORTED WRIST RESTRAINTS ON PATIENT TO PREVENT SELF EXTUBATION/CLINICAL LINE REMOVAL, MATERIALS RIPPED AT VELCRO/PADDING WHEN PATIENT PULLED AGAINST DEVICE, DEVICE FAILURE ALLOWED PATIENT TO REMOVE CRITICAL LINE RESULTING IN CARDIAC ARREST.

  Patient problems: Cardiac Arrest

  MAUDE report 20053997 ↗
• MalfunctionAug 23, 2024Break; Break

  A CUSTOMER INFORMED US OF A CRITICAL ISSUE IDENTIFIED WITH THE RESTRAINT WHERE THEY WILL NO LONGER BE USING PART NUMBER 2510 WILL BE REPLACING WITH PART NUMBER 2532.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20051238 ↗
• DeathAug 18, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  WE RECEIVED AN FDA MEDWATCH INDICATING THAT A PATIENT WHO WAS VENTILATOR-DEPENDENT WITH PAST MEDICAL HISTORY OF ACUTE LEFT MCA STROKE WITH RIGHT HEMIPARESIS AND SEVERE APHASIA WAS ADMITTED FROM A TRANSITIONAL CARE FACILITY FOR AGITATION AND CLOSE OBSERVATION. PATIENT SELF-REMOVED THEIR TRACHEOSTOMY TUBE AND STAFF WAS ABLE TO REPLACE TRACH. MEDS WERE ADMINISTERED TO CALM PATIENT DOWN FROM AN AGITATED STATE. THE PATIENT WAS TRANSFERRED TO THE ICU FOR CLOSE MONITORING WHERE BILATERAL WRIST RESTRAINTS WERE INITIATED AS PATIENT WAS PULLING AT TUBES/TRACH. THE RIGHT RESTRAINT WAS REMOVED DUE TO RIGHT HEMIPARESIS. THE PATIENT WAS TRANSFERRED OUT OF THE ICU. THE PATIENT WAS AGITATED, KICKING, CRYING AND YANKING AT THE RESTRAINT TRYING TO PULL THE TRACH OUT. THE PATIENT WAS REPOSITIONED AND THE RESTRAINT WAS NOTED AS BEING REALLY TIGHT AND THE NURSE HAD RETIED THE RESTRAINT. PATIENT WAS REDIRECTED, REORIENTED, NO LONGER PULLING AT TRACH. RESTING COMFORTABLY IN BED. AT THE TIME OF THE NEXT HOURLY CHECK, THE PATIENT WAS FOUND UNCONSCIOUS, CPR INITIATED AND PATIENT EXPIRED. PATIENT HAD INTENTIONALLY PULLED OUT TRACH. NURSE REPORTED THAT THE RESTRAINT WAS STILL ON THE PATIENT'S WRIST AND WAS TI

  Patient problems: Irritability; Loss of consciousness; Ventilator Dependent

  MAUDE report 15250684 ↗