DeRoyal 13400007Recalls & reported problems
Deroyal Industries, Inc. · Solace Back Support · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- 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 00749756620994), received between Dec 8, 2022 and Dec 8, 2022 — classified as 1 malfunction.
The most frequently reported specific device problem is “Manufacturing, Packaging or Shipping 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Manufacturing, Packaging or Shipping Problem1
- Sharp Edges1
Patient problems
- Hemorrhage/Blood Loss/Bleeding1
- Laceration(s)1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 8, 2022Manufacturing, Packaging or Shipping Problem; Sharp Edges; Manufacturing, Packaging or Shipping Problem; Sharp Edges
MY ORTHOPEDIC DOCTOR ORDERED A DEROYAL BACK BRACE FOR ME. THE FIRST DAY I WORE IT, THE EDGES OF THE VELCRO SLICED MY ARM OPEN TWICE. BOTH INJURIES BLED ENOUGH THAT I HAD TO PUT PRESSURE AND BANDAGE THEM. THE ENDS ARE HARD AND SHARP, AND I WILL NOT BE ABLE TO CONTINUE USING THIS BRACE.
Patient problems: Hemorrhage/Blood Loss/Bleeding; Laceration(s)
MAUDE report 15944933 ↗
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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