DeRoyal 30-101Recalls & reported problems
Deroyal Industries, Inc. · Kittner Sponge · Class 1
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00749756024396), received between Jan 7, 2021 and Aug 12, 2024 — classified as 6 malfunctions.
The most frequently reported specific device problem is “Material Fragmentation” (3 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
- Material Fragmentation3
- Material Disintegration2
- Material Integrity Problem2
- Detachment of Device or Device Component1
- Separation Failure1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Foreign Body In Patient1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 12, 2024Material Fragmentation; Material Fragmentation
A USER FACILITY REPORTED, "KITTNER SPONGES ARE BREAKING OFF WITH MINIMAL FORCE AND SURGEON IS FINDING PIECES. THIS IS FOR DR (B)(6) TOTAL THYROIDECTOMY."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19960651 ↗MalfunctionAug 12, 2024Material Fragmentation; Material Fragmentation
A USER FACILITY REPORTED, "KITTNER SPONGES ARE BREAKING OFF WITH MINIMAL FORCE AND SURGEON IS FINDING PIECES. THIS IS FOR DR (B)(6) TOTAL THYROIDECTOMY."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19960643 ↗MalfunctionAug 12, 2024Material Fragmentation; Material Fragmentation
A USER FACILITY REPORTED, "KITTNER SPONGES ARE BREAKING OFF WITH MINIMAL FORCE AND SURGEON IS FINDING PIECES. THIS IS FOR DR (B)(6) TOTAL THYROIDECTOMY."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19960636 ↗MalfunctionMar 25, 2021Separation Failure; Detachment of Device or Device Component; Separation Failure; Detachment of Device or Device Component
A PHYSICIAN COMPLAINT OF THE KITTNER SPONGE, 30-101. THE PHYSICIAN SHARED THAT THEY ARE FALLING APART AND POTENTIALLY LEAVING PIECES PRODUCT IN THE PATIENT.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 11569152 ↗MalfunctionFeb 4, 2021Material Disintegration; Material Integrity Problem; Material Disintegration; Material Integrity Problem
THE KITTNER SPONGE IS COMING APART AND LEAVING SMALL RADIOPAQUE PIECES IN THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11279846 ↗MalfunctionJan 7, 2021Material Disintegration; Material Integrity Problem
THE SPONGE'S RADIOPAQUE STRIP BECOMES DETACHED AND MAY BE LEFT IN WOUND. THE SPONGE CREATES FIBERS, WHICH CAN BE LEFT IN PATIENT.
Patient problems: Foreign Body In Patient
MAUDE report 11134136 ↗
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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.