MAUDE Adverse Event Report: CARDINAL HEALTH 200, LLC DERMACEA; GAUZE/SPONGE,NONRESORBABLE FOR EXTERNAL USE

Model Number	441106
Medical Device Problem Codes	Material Fragmentation (1261); Material Frayed (1262)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device history record (dhr) for lot: e24062121s was reviewed and no anomalies related to the reported issue were observed.Prior to a lot¿s release, the lot must be deemed acceptable by-passing inspections that are based on a valid sampling plan.During production, inspectors routinely examine a statistical sample both physically and visually.A photo was provided for evaluation and the reported issues were confirmed.However, physical samples are required to further investigate the root cause.At this time, no physical samples have been provided.As such, a root cause could not be determined.We will continue to monitor related reports to determine if additional actions are necessary.
Event or Problem Description
The customer reported that the large cotton gauze/wrap is noticeably thinner, prone to fraying, and leaving rough edges that can cause cotton debris in wounds.Because of its fragility, staff often need to use more product to achieve appropriate coverage.Additional information received on 21oct2025 stated that the weaves on this brand are wide requiring double the layers.The rolls fray on the ends and most especially when cut causing fragments to fall off.They are not aware of any situation where debris was in a wound, but are concerned it could happen.The rolls are used in both a clinical and surgical setting.

• Brand Name: DERMACEA
• Common Device Name: GAUZE/SPONGE,NONRESORBABLE FOR EXTERNAL USE
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC; 3651 birchwood drive; waukegan IL 60085
• Manufacturer (Section G): CARDINAL HEALTH; 3651 birchwood drive; waukegan IL 60085
• Manufacturer Contact: jill saraiva ; 3651 birchwood drive; waukegan, IL 60085 ; 5086183640
• MDR Report Key: 23459006
• Report Number: 1423537-2025-00450
• Device Sequence Number: 7875593
• Product Code: NAB
• UDI-Device Identifier: 10192253048704
• UDI-Public: (01)10192253048704(10)E24062121S
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/03/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 441106
• Device Catalogue Number: 441106
• Device Lot Number: E24062121S
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/08/2025
• Initial Report FDA Received Date: 11/03/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown