MAUDE Adverse Event Report: CARDINAL HEALTH 200, LLC WEBCOL; PAD, ALCOHOL, DEVICE DISINFECTANT

Model Number	5110
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Skin Inflammation/ Irritation (4545)
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 they think they may have an infection because of the alcohol prep.Additional information received stated the patient was using the alcohol preps to clean his leg to start a new site for a remodulin injection sub q.The patient's leg became painful more than normal and swelled up 3 inches more than normal.His leg had a 102 temp on it until he removed the site and cleaned it very well.The injection point is still very red, and the patient still has pain.The redness on the rest of the leg has started to go away.The pain is tolerable now which is different than any other site reaction that the patient has gotten from the medicine.The patient did not see a doctor but did speak to his pharmacist.No medications were required.
Additional Manufacturer Narrative
A non-conformance record review for the reported lot number was conducted.All in-process and final acceptance inspections were performed in accordance with established procedures.There were no devices or photos returned for evaluation; therefore, the affected device could not be evaluated, and a definitive root cause could not be determined.However, a corrective and preventive action has been initiated to further investigate the reported issue.We will continue to monitor and take additional actions, as applicable.

• Brand Name: WEBCOL
• Common Device Name: PAD, ALCOHOL, DEVICE DISINFECTANT
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC; 3651 birchwood drive; waukegan IL 60085
• Manufacturer (Section G): CARDINAL HEALTH; 1430 marvin griffin road, po b; augusta GA 30906
• Manufacturer Contact: jill saraiva ; 3651 birchwood drive; waukegan, IL 60085 ; 5086183640
• MDR Report Key: 24775920
• Report Number: 1423537-2026-00098
• Device Sequence Number: 21304403
• Product Code: LKB
• UDI-Device Identifier: 10192253046205
• UDI-Public: (01)10192253046205(10)25K041462
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/15/2026

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: 5110
• Device Catalogue Number: 5110
• Device Lot Number: 25K041462
• 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: 03/22/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/03/2026
• Supplement Report FDA Received Date: 06/15/2026
• Date Device Manufactured: 10/31/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male