POSEY 2810Recalls & reported problems
Posey Products, LLC · HAND MITT · Class 1
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10190676005380), received between Oct 12, 2022 and Oct 19, 2023 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Material Frayed” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Material Frayed4
Patient problems
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 19, 2023Material Frayed; Material Frayed
CUSTOMER IS REPORTING A COMPLAINT ON PRODUCT # 2810. CUSTOMER STATES THAT A PATIENT WAS ABLE TO SCRATCH AND THEN PULL AWAY THE INNER LINING AT THE STITCHING SEAM TO EXPOSE THE FOAM BALLS THAT ARE INSIDE THE MITT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17970216 ↗MalfunctionOct 19, 2022Material Frayed; Material Frayed
CUSTOMER REPORTED VIA EMAIL THE PATIENT BIT THROUGH HER MITTENS SENDING BEADS EVERYWHERE IN A PATIENT THAT WAS AT RISK OF ASPIRATION. THIS WAS THE 3RD REPORTED INCIDENT WITH THE MITTS TEARING OR BREAKING CAUSING BEADS TO BE EXPOSED TO PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15633988 ↗MalfunctionOct 19, 2022Material Frayed; Material Frayed
CUSTOMER REPORTED VIA EMAIL THEY HAD A PATIENT WHO WAS FOUND WITH CONTENTS OF MITTEN ALL OVER HER BED. MITTEN WAS REMOVED AND REPLACED WITH A NEW ONE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15633860 ↗MalfunctionOct 12, 2022Material Frayed; Material Frayed
CUSTOMER REPORTED TO TM THAT THE MITTS ARE SPLITTING OPEN AND COULD POTENTIALLY CAUSE HARM TO THE PATIENTS IF THE BEADS ARE SWALLOWED. THEY MENTIONED THE PATIENTS ARE CLAWING THROUGH THEM AND BITING THE MITTS, BUT ARE CONCERNED ABOUT THE DAMAGE FROM THESE MITTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15588600 ↗
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- 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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