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 Code	Rash (2033)
Date of Event	02/12/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported via medwatch that the reporter's daughter started developing a rash on her arm on (redacted by fda) 2026.This got increasingly worse and they sought medical help.They were later informed via amazon about the webcol alcohol wipes and this is how they connected the dots.Additional information received on 15may2026 stated that they are not sure what the lot number is.The patient was seen by a dermatologist and they did prescribe mometasone cream.However, they didn¿t use the cream as the rash started clearing with home remedies used.
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.

• 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: 25355442
• Report Number: 1423537-2026-00174
• Device Sequence Number: 9892269
• Product Code: LKB
• UDI-Device Identifier: 10192253046205
• UDI-Public: 10192253046205
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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): 07/15/2026

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
• 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: 05/14/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/01/2026
• Supplement Report FDA Received Date: 07/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Female