DermaceaRecalls & reported problems across all models
Cardinal Health, Inc. · 5 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 22
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls
- 0
We found 5 models of Dermacea by Cardinal Health, Inc. in the FDA's device registry (GUDID). Together they are named in 22 adverse event reports in the FDA's MAUDE database, received between Sep 13, 2019 and Jun 6, 2024 — classified as 2 injuries, 20 malfunctions.
The most frequently reported specific device problem is “Material Fragmentation” (9 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Dermacea problems
Device problems
- Material Fragmentation9
- Component Missing5
- Material Frayed5
- Device Misassembled During Manufacturing /Shipping3
- Material Disintegration2
- Nonstandard Device1
Patient problems
- No Clinical Signs, Symptoms or Conditions10
- No Consequences Or Impact To Patient6
- Insufficient Information4
- Foreign Body In Patient2
- Inflammation1
- No Patient Involvement1
- Unspecified Infection1
Dermacea models
5 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Dermacea 441601GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE17 reports
- Dermacea 441002GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE2 reports
- Dermacea 441000Gauze / Sponge,Nonresorbable For External Use1 report
- Dermacea 441602GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE1 report
- Dermacea 441604GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE1 report
Recent Dermacea adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionJun 6, 2024Component Missing; Component Missing
THE CUSTOMER REPORTED RECEIVING 9 OUT OF 10 GAUZES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19476846 ↗MalfunctionAug 30, 2022Material Frayed; Material Frayed
THE CUSTOMER REPORTED THAT THE GAUZE IS FRAYING WHEN USED. ADDITIONAL INFORMATION RECEIVED STATED THAT THE GAUZE WAS USED IN THE OPERATING ROOM AND DELIVERY ROOM. WHEN THE DOCTORS USE IT AND REMOVE IT FROM WHERE THEY PLACE IT IN THE PATIENT, THE THREAD COMES OUT AND THE GAUZE FRAYS LITTLE BY LITTLE; THE THREAD DOESN¿T COME OUT COMPLETELY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15319254 ↗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 ↗MalfunctionJan 7, 2022Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping
THE CUSTOMER REPORTED THAT THE PACKAGE CONTAINED 9 PIECES INSTEAD OF 10.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13192588 ↗MalfunctionDec 28, 2021Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping
THE CUSTOMER REPORTED THAT ONE PACK OF SPONGES CONTAINED 11 PIECES INSTEAD OF 10 AND ANOTHER CONTAINED 9 INSTEAD OF 10. NO INJURIES OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13094399 ↗MalfunctionSep 15, 2021Component Missing; Component Missing
CUSTOMER REPORTS: THE PACKAGE CONTAINED 5 GAUZE INSTEAD OF 10.
Patient problems: Insufficient Information
MAUDE report 12476343 ↗MalfunctionSep 8, 2021Material Fragmentation; Material Fragmentation
THE CUSTOMER REPORTED THAT THERE WAS LINTING ON THE LAP SPONGES. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12438700 ↗MalfunctionMay 24, 2021Material Frayed; Material Frayed
CUSTOMER REPORTS: THE RAYTEC SPONGES ARE SHREDDING.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 11870406 ↗MalfunctionApr 15, 2021Component Missing; Component Missing
THE CUSTOMER REPORTED THAT THE GAUZE ONLY HAD 8 EACH INSTEAD OF 10 EACH. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11673263 ↗InjuryApr 1, 2021Material Fragmentation; Material Fragmentation
THE CUSTOMER STATED THERE WAS A WHITE SUBSTANCE THAT APPEARED TO BE LINT, FALLING FROM THE GAUZE. THE LINT FELL INTO THE PATIENT'S OPEN WOUND AND THE SURGEON IRRIGATED THE WOUND TO REMOVE IT.
Patient problems: Foreign Body In Patient
MAUDE report 11604141 ↗MalfunctionJan 27, 2021Material Fragmentation; Material Fragmentation
THE CUSTOMER REPORTED THAT THE GAUZE WAS COMING APART. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11240045 ↗MalfunctionDec 17, 2020Material Disintegration; Material Frayed; Material Disintegration; Material Frayed
THE CUSTOMER REPORTED THAT THE RAYTEC GAUZE IS FRAYING. THE ISSUE WAS DISCOVERED DURING A PROCEDURE. THE RAYTEC WAS REMOVED FROM FIELD AND A NEW PACK OPENED. THEY TRIED TO REMOVE AS MANY LOOSE THREADS AS POSSIBLE. THERE WAS NO DELAY TO THE CASE AND NO SIGNS OF HARM TO PATIENT AS OF NOW. ON 16-DEC-2020 ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE RAYTEC WAS FRAYING AND SHEDDING AND TO THEIR KNOWLEDGE THERE WERE NONE WENT INSIDE THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11033579 ↗MalfunctionDec 16, 2020Material Fragmentation; Material Frayed
RAYTEC GAUZE IS FRAYING AND LEAVING THREADS ON STERILE FIELD. THERE WAS PATIENT CONTACT. RAYTEC WAS REMOVED FROM FIELD, AND A NEW PACK OF RAYTEC WAS OPENED. TRIED TO REMOVE AS MANY LOOSE THREADS AS POSSIBLE. THE GAUZE WAS CONTAINED IN ROI CPS, LLC CUSTOM PACK 880087014, LOT #: 82828N, GS00087N.
Patient problems: Insufficient Information
MAUDE report 11015570 ↗MalfunctionNov 24, 2020Material Fragmentation; Material Fragmentation
THE CUSTOMER REPORTED THE RAYTEC GAUZE IS FRAYING AND LEAVING THREADS ON STERILE FIELD. THERE WAS NO HARM TO THE PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10895364 ↗MalfunctionNov 24, 2020Material Fragmentation; Material Fragmentation
THE CUSTOMER REPORTED THE RAYTEC GAUZE IS FRAYING AND LEAVING THREADS ON THE STERILE FIELD. THERE WAS NO HARM TO THE PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10895318 ↗
Other Cardinal Health, Inc. products
All Cardinal Health, Inc. devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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