DeRoyal A111009Recalls & reported problems
Deroyal Industries, Inc. · Shoulder Immobilizer · 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 00749756611763), received between Sep 10, 2025 and Sep 10, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Patient Device Interaction Problem” (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
Most reported problems
Device problems
- Patient Device Interaction Problem1
Patient problems
- Blister1
- Burning Sensation1
- Hypersensitivity/Allergic reaction1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjurySep 10, 2025Patient Device Interaction Problem; Patient Device Interaction Problem
AN END USER REPORTED, "PATIENT HAD AN ALLERGIC REACTION TO THE BICEP CUFF."
Patient problems: Blister; Burning Sensation; Hypersensitivity/Allergic reaction
MAUDE report 23017347 ↗
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.