Dermacea 441604Recalls & reported problems

Cardinal Health, Inc. · X-Ray Sponges,16 Ply · 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 10884527021079), received between Apr 4, 2022 and Apr 4, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Material Fragmentation” (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.

Most reported problems

Device problems

Material Fragmentation1

Patient problems

Foreign Body In Patient1
Inflammation1
Unspecified Infection1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

InjuryApr 4, 2022Material Fragmentation; Material Fragmentation
THE CUSTOMER REPORTED THAT THE PRODUCT IS COMING APART DURING THE SURGERY AND LITTLE PARTICLES ARE COMING OFF THE RAYTEC. THE SURGEONS STATED THE PATIENT GOT AN INFECTION. ADDITIONAL INFORMATION RECEIVED ON 28-MAR-2022 STATED THAT THE SURGERY BEING PERFORMED WAS A BILATERAL BREAST AUGMENTATION WHICH TOOK PLACE ON (B)(6) 2022. THE GAUZE WAS UNFOLDED DURING USE. THE PARTICLES FELL INSIDE THE PATIENT. THE PARTICLES WERE REMOVED, BUT THE REPORTER DID NOT STATE WHICH TECHNIQUE WAS USED FOR REMOVAL. THE PATIENT DEVELOPED INFLAMMATION ONE WEEK AFTER THE PROCEDURE AND WAS TREATED WITH ANTIBIOTICS. ADDITIONAL TREATMENT FOR THE INFECTION WAS NOT CLEAR IN THE CUSTOMER'S RESPONSE. THE PATIENT IS IN STABLE CONDITION.
Patient problems: Foreign Body In Patient; Inflammation; Unspecified Infection
MAUDE report 13995875 ↗

Device details

UDI-DI	`10884527021079`
Brand	Dermacea
Model	441604
Company	Cardinal Health, Inc.
Product code	GDY · GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE
Class	Class 1
FDA submission	None listed
Implant	No
Rx / OTC	OTC
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	Not in Commercial Distribution
Record updated	Dec 31, 2025

Device type (GMDN): Radiopaque woven surgical sponge

A non-medicated device made from woven gauze (e.g., cotton, cellulose) primarily intended to be used inside the body, on a surgical incision or applied to internal organs or structures to control bleeding, absorb fluid, or protect organs or structures from abrasion, drying, or contamination during a procedure; also referred to as a laparotomy sponge, it may also be used for prepping the patient. It contains an x-ray detectable marker [e.g., a thread or strand(s)] to help detect gossypiboma (sponge left inside patient). This is a single-use device.

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All GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.