DeRoyal 13652067Recalls & reported problems
Deroyal Industries, Inc. · ABDOMINAL BINDER · 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 00749756283236), received between Oct 12, 2023 and Oct 12, 2023 — 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
- Rash1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryOct 12, 2023Patient Device Interaction Problem; Patient Device Interaction Problem
THE PATIENT DEVELOPED A RASH. PATIENT DISCONTINUED THE USE OF THE BINDER, BUT RASH DID SPREAD.
Patient problems: Rash
MAUDE report 17923910 ↗
Other BINDER, ABDOMINAL devices
- DeRoyal 13662067Deroyal Industries, Inc. · BINDER, ABDOMINAL14 reports
- DeRoyal 13661056Deroyal Industries, Inc. · BINDER, ABDOMINAL1 report
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.