POSEY 4125Recalls & reported problems
Posey Products, LLC · POSEY SOFT BELT W/TIES · Class 1
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 1
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10190676003447), received between Dec 13, 2022 and Dec 13, 2022 — classified as 1 death.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (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.
Most reported problems
Device problems
- Insufficient Device Problem Information1
Patient problems
- Head Injury1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
DeathDec 13, 2022Insufficient Device Problem Information; Insufficient Device Problem Information
CUSTOMER HAS ISSUED A COMPLAINT ON PRODUCT (B)(4). REPORTER STATES HER MOTHER WAS AT (B)(6). WHILE THERE AT THE HOSPITAL, THEY TOLD HER THAT HER MOTHER HAD AN UNWITNESSED FALL (WHICH SHE DIDNT BELIEVE TO BE TRUE). SHE SENT A HUBSPOT ASKING IF A PERSON COULD GET OUT OF THE (B)(4) BY SLIDING FORWARD.
Patient problems: Head Injury
MAUDE report 15974023 ↗
Other Restraint, Protective devices
- DeRoyal M8138Deroyal Industries, Inc. · Restraint, protective1 recall1 report
- DeRoyal M8137Deroyal Industries, Inc. · Restraint, protective1 recall0 reports
- DeRoyal M8136Deroyal Industries, Inc. · Restraint, protective1 recall0 reports
- DeRoyal M8125Deroyal 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 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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