POSEY 2789QRecalls & reported problems
Posey Products, LLC · POSEY QR TAT CUFF · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10190676003195), received between Jan 3, 2025 and Apr 29, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Break1
Patient problems
- Abrasion1
- Insufficient Information1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 29, 2026Break
CUSTOMER REPORTING COMPLAINT ON THE PRODUCT 2798Q. CUSTOMER STATES THAT PRODUCT BROKE WHILE A PATIENT WAS USING IT. AS A RESULT A STAFF MEMBER WAS INJURED. THERE ARE NO DETAILS INCLUDED ABOUT THE NATURE OF THE INJURY OR THE SITUATION OF THE PATIENT. JUST THAT THERE WAS A FAILURE AND A STAFF MEMBER WAS HURT.
Patient problems: Abrasion
MAUDE report 25032494 ↗MalfunctionJan 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
CUSTOMER REPORTING A COMPLAINT ON PRODUCT 2789Q, LOT 4151T020. (B)(6) FDA COMPLAINT# (B)(4), CUSTOMER STATES THEY HAD JUST RESTRAINED AN AGGRESSIVE PATIENT. THEY USED THE TWICE AS TOUGH RESTRAINTS 2789Q. CUSTOMER OBSERVED THAT THE PATIENT WAS ABLE TO FOLLOW THE LINE THAT ATTACHED HIS WRIST TO THE BED. THE PATIENT WAS THEN ABLE TO UNCLASP THE BUCKLE AND FREE HIS HAND. CUSTOMER STATES THAT THE RESTRAINT KEPT PATIENT FROM RAISING ARM OFF THE BED, BUT DID NOT PREVENT HIM FROM MOVING HAND TOWARDS BEDFRAME WHERE THE RESTRAINT WAS SECURED TO THE BED.
Patient problems: Insufficient Information
MAUDE report 21071807 ↗
Other Restraint, Protective devices
- DeRoyal M8138Deroyal Industries, Inc. · Restraint, protective1 recall1 report
- DeRoyal M8125Deroyal Industries, Inc. · Restraint, protective1 recall0 reports
- DeRoyal M8137Deroyal Industries, Inc. · Restraint, protective1 recall0 reports
- DeRoyal M8136Deroyal Industries, Inc. · Restraint, protective1 recall0 reports
- DeRoyal M8124Deroyal Industries, Inc. · Restraint, protective1 recall0 reports
- POSEY 2532Posey Products, LLC · Restraint, Protective36 reports
- POSEY 2551Posey Products, LLC · Restraint, Protective14 reports
- POSEY 2799Posey Products, LLC · Restraint, Protective9 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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