POSEY 4734Recalls & reported problems

Posey Products, LLC · POSEY CHILD LIMB HOLDERS · 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 10190676003348), received between Nov 14, 2023 and Nov 14, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Too Soft/Flexible” (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

Material Too Soft/Flexible1

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.

MalfunctionNov 14, 2023Material Too Soft/Flexible; Material Too Soft/Flexible
CUSTOMER REPORTED A COMPLAINT VIA EMAIL STATING THEY HAVE NOTICED THAT THE VELCRO ON THE NEW INFANT MED-SURG RESTRAINTS IS NOT VERY STRONG. THEY HAVE FOUND THEY HAVE TO MASSAGE THE VELCRO TO GET IT TO ADHERE, BUT THEN AFTER SECURING A COUPLE OF TIMES, EVEN WITH MASSAGING THE VELCRO, IT DOES NOT ADHERE VERY WELL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18131951 ↗

Device details

UDI-DI	`10190676003348`
Brand	POSEY
Model	4734
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 14, 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.