DeRoyal M1018-URecalls & reported problems
Deroyal Industries, Inc. · Body Belt · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00749756162494), received between Jan 11, 2024 and Jan 11, 2024 — classified as 2 injuries.
The most frequently reported specific device problem is “Difficult or Delayed Separation” (2 reports).
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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Difficult or Delayed Separation2
Patient problems
- Choking2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJan 11, 2024Difficult or Delayed Separation; Difficult or Delayed Separation
THE PATIENT HAD WAIST RESTRAINT CHOKE THEM WHERE NURSE WAS NOT ABLE TO RELEASE RESTRAINT WITH QUICK RELEASE BUCKLE. HAD TO CUT STRAP TO RELEASE CHOKING HAZARD.
Patient problems: Choking
MAUDE report 18495769 ↗InjuryJan 11, 2024Difficult or Delayed Separation; Difficult or Delayed Separation
THE PATIENT HAD WAIST RESTRAINT CHOKE THEM WHERE NURSE WAS NOT ABLE TO RELEASE RESTRAINT WITH QUICK RELEASE BUCKLE. HAD TO CUT STRAP TO RELEASE CHOKING HAZARD.
Patient problems: Choking
MAUDE report 18495698 ↗
Other Restraint, protective devices
- DeRoyal M8138Deroyal Industries, Inc. · Restraint, protective1 recall1 report
- DeRoyal M8125Deroyal Industries, Inc. · Restraint, protective1 recall0 reports
- DeRoyal M8137Deroyal Industries, Inc. · Restraint, protective1 recall0 reports
- DeRoyal M8136Deroyal Industries, Inc. · Restraint, protective1 recall0 reports
- DeRoyal M8124Deroyal Industries, Inc. · Restraint, protective1 recall0 reports
- POSEY 2532Posey Products, LLC · Restraint, Protective36 reports
- POSEY 2551Posey Products, LLC · Restraint, Protective14 reports
- POSEY 2799Posey Products, LLC · Restraint, Protective9 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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