DeRoyal 30-106Recalls & reported problems
Deroyal Industries, Inc. · Peanut Sponge · Class 1
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00749756024280), received between Apr 8, 2021 and Jul 28, 2025 — classified as 1 injury, 3 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Detachment of Device or Device Component2
- Material Disintegration2
- Material Separation2
- Separation Problem2
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
- Insufficient Information1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryJul 28, 2025Material Disintegration; Material Disintegration
A USER FACILITY REPORTED, "PEANUT SPONGE SUPPLY (REFERENCE # (B)(4)) BLUE RADIOPAQUE FIBER FLAKED OFF DURING PROCEDURE."
Patient problems: Insufficient Information
MAUDE report 22629868 ↗MalfunctionAug 7, 2024Material Disintegration; Material Disintegration
THE BLUE XTRAY INDICATOR ON THE PEANUT SPONGE IS DISINTEGRATING DURING USE. PATIENT WAS NOT INJURED BUT CUSTOMER NOTED THE RISK OF LEAVING FOREIGN MATTER BEHIND IN THE OPERATIVE AREA IF NOT CORRECTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19928469 ↗MalfunctionApr 8, 2021Material Separation; Detachment of Device or Device Component; Separation Problem; Material Separation; Detachment of Device or Device Component; Separation Problem
SHEDDING THE BLUE XRAY DETECTABLE STRING DURING SURGERY.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions
MAUDE report 11636058 ↗MalfunctionApr 8, 2021Material Separation; Detachment of Device or Device Component; Separation Problem; Material Separation; Detachment of Device or Device Component; Separation Problem
SHEDDING THE BLUE XRAY DETECTABLE STRING DURING SURGERY.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions
MAUDE report 11636056 ↗
Other GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE devices
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- Situate G0404-16P01CN-1Covidien LP · GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE114 reports
- 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.