DeRoyal M8125-CRecalls & reported problems

Deroyal Industries, Inc. · IV ARMBOARD · Class 1

Adverse event reports: 1
Deaths reported: 0
Injuries reported: 1
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00749756112482), received between Aug 7, 2024 and Aug 7, 2024 — classified as 1 injury.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (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

Patient-Device Incompatibility1

Patient problems

Abrasion1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

InjuryAug 7, 2024Patient-Device Incompatibility; Patient-Device Incompatibility
"WE RECEIVED COMPLAINTS THAT THE ARM BOARDS ARE ABRASIVE AND PATIENTS WERE BEING CUT BY THEM. WE ARE UNABLE TO USE THESE. PLEASE PROVIDE RETURN PAPERWORK. THANK YOU."
Patient problems: Abrasion
MAUDE report 19928775 ↗

Device details

UDI-DI	`00749756112482`
Brand	DeRoyal
Model	M8125-C
Company	Deroyal Industries, Inc.
Product code	KMK · DEVICE, INTRAVASCULAR CATHETER SECUREMENT
Class	Class 1
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	No
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Aug 5, 2021

Device type (GMDN): Freestanding patient positioner, single-use

A preformed patient-contact device (e.g., cushion, pad, bolster, wedge, elevation pillow) designed to be placed freely on a flat surface (e.g., operating table, stretcher) to position and stabilize a patient or body part typically in preparation for and during various medical procedures [e.g., to align the head, neck and thorax to optimise laryngoscopy in anaesthesia]; it is not attached to a parent device. It is made of shock-absorbing materials (e.g., memory foam) to reduce pressure on the bony prominences of a body part (e.g., torso, arm, leg), and some types are inflatable to provide variable support (e.g., to level the spine in a lateral position). This is a single-use 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.