DeRoyal 9387-00Recalls & reported problems
Deroyal Industries, Inc. · FOAM WRAP, KNEE · 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 00749756101981), received between Oct 16, 2023 and Oct 16, 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
- Use of Device Problem1
Patient problems
- Blister1
- Rash1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryOct 16, 2023Use of Device Problem; Patient Device Interaction Problem; Use of Device Problem; Patient Device Interaction Problem
THE SKIN DISCOLORATION AND BLISTERS OCCURRED WITH ONE REPORTED PATIENT.
Patient problems: Blister; Rash
MAUDE report 17940076 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.