POSEY 1135Recalls & reported problems
Posey Products, LLC · POSEY SR ROLL BELT · Class 1
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10190676003362), received between Jun 27, 2025 and Jun 27, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Labelling, Instructions for Use or Training Problem” (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.
Reports received per month
Most reported problems
Device problems
- Labelling, Instructions for Use or Training Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 27, 2025Labelling, Instructions for Use or Training Problem; Labelling, Instructions for Use or Training Problem
MDR REPORT RECEIVED FROM FDA. CUSTOMER REPORT# MW5170531. IT WAS REPORTED THE POSEY SELF RELEASE ROLL BELT HAVE INCONSISTENT INSTRUCTIONS IN THE BOX. NOT ALL OF THE BOXES INCLUDE CONTRAINDICATIONS. ACCORDING TO THE IFU, THESE STYLE BELTS MAY PRESENT A PATIENT SAFETY RISK IF USED WITH PATIENTS THAT ARE UNWILLING OR UNABLE TO FOLLOW DIRECTIONS/INSTRUCTIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22346516 ↗
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- POSEY 2532Posey Products, LLC · Restraint, Protective36 reports
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.