DeRoyal 30-045Recalls & reported problems
Deroyal Industries, Inc. · CYLINDRICAL SPONGES · Class 1
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00749756028332), received between Apr 8, 2021 and Aug 9, 2024 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (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
- Insufficient Device Problem Information1
- Radiation Output Failure1
- Radiation Output Problem1
Patient problems
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryAug 9, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
A USER FACILITY REPORTED, " IT COMES OUT IN THE THROAT OF PATIENTS....... SO VERY PROBLEMATIC IN SURGERY FOR TONSILS. SEVERAL PACKAGING MUST BE DISCARDED AS THEY ARE UNUSABLE (BUDGETARY CONSEQUENCE). PRODUCT STERILITY MAY BE COMPROMISED (RISK TO USER)" THE SPECIFIC PROBLEM OR ADVERSE EVENT THAT OCCURRED BECAUSE OF THE PROBLEM WERE NOT DESCRIBED.
Patient problems: Insufficient Information
MAUDE report 19950640 ↗MalfunctionApr 8, 2021Radiation Output Problem; Radiation Output Failure; Radiation Output Problem; Radiation Output Failure
RADIOPAQUE COTTONWOOD SPONGE DID NOT SHOW UP ON X-RAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11637185 ↗
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- Situate G0804-16P02CN-1Covidien LP · GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE2 recalls1 report
- Situate L1818-04P01C-1Covidien LP · GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE1 recall20 reports
- Situate G0404-16P01C-1Covidien LP · GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE60 reports
- AMD-RITMED 55992CAMD Medicom Inc · GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE1 recall0 reports
- AMD-RITMED 85995CAMD Medicom Inc · GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE1 recall0 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.