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

Model Number	9190A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Skin Inflammation/ Irritation (4545)
Date of Event	03/13/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Event or Problem Description
The customer reported that over the last 4-5 weeks, patients are getting reactions so bad to the product, it looks like burns in a perfect outline of the abdominal pad shape.They are having to treat patients with antibiotics for it.Per additional information received, it was a burn like reaction in the shape of the abdominal pads.The patients were prescribed prednisone.The only relief they got was when the abdominal pads were removed.Photos cannot provide photos due to patient privacy.
Additional Manufacturer Narrative
Corrected the lot number and udi number in section d4.A non-conformance review was conducted for lot 24k047962 and there were no ncs related to the reported event issued during the manufacturing of this lot.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.There were no samples returned for evaluation; therefore the affected device(s) could not be evaluated to confirm the reported failure mode.As such, a root cause could not be determined.We will continue to monitor related reports to determine if additional actions are necessary.

• Brand Name: CURITY
• 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 200, LLC; 1430 marvin griffin road, po b; augusta GA 30906
• Manufacturer Contact: jill saraiva ; 3651 birchwood drive; waukegan, IL 60085 ; 5086183640
• MDR Report Key: 21697320
• Report Number: 1423537-2025-00140
• Device Sequence Number: 15718025
• Product Code: NAB
• UDI-Device Identifier: 10192253047912
• UDI-Public: (01)10192253047912(17)290930(10)24KO47962
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/18/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 9190A
• Device Catalogue Number: 9190A
• Device Lot Number: 24K047962
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/13/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/26/2025
• Supplement Report FDA Received Date: 04/18/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown