POSEY 4126QRecalls & reported problems

Posey Products, LLC · POSEY SR PADDED 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 10190676003485), received between Aug 20, 2025 and Aug 20, 2025 — classified as 1 malfunction.

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. How this data works · Data updated Oct 13, 2026.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Break1

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.

MalfunctionAug 20, 2025Break; Break
CUSTOMER REPORTING A COMPLAINT ON PRODUCT (B)(4) SELF RELEASING SEAT BELT LOT 5098T224. CUSTOMER STATES THAT THE SELF RELEASING SEAT BELT RIPPED IN HALF LEADING TO A PATIENT FALL. REPORT DOES NOT STATE ANY INJURIES OR DEATH AS A RESULT OF THE FALL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22850020 ↗

Device details

UDI-DI	`10190676003485`
Brand	POSEY
Model	4126Q
Company	Posey Products, LLC
Product code	FMQ · Restraint, Protective
Class	Class 1
FDA submission	None listed
Implant	No
Rx / OTC	OTC
Single use	No
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Oct 12, 2022

Device type (GMDN): Limb/torso/head restraint, reusable

A non-rigid device, typically a strap(s) or band(s) or garment-like, intended to be temporarily placed on or around one or more parts of a patient’s body (e.g., torso, limbs, head) to restrict movement, to facilitate patient positioning and stabilization during a medical procedure, and/or to prevent injury/hazards while potentially permitting limited movement. It is made of various materials (e.g., fabric, nylon, leather, or foam) and typically anchored to a fixture or furniture part (e.g., a bedrail, operating table). It is not intended for immobilization of specific joint. This is a reusable device.

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.