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	Unspecified Infection (1930); Sepsis (2067)
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer reported that her husband was diagnosed with stage 4 bile duct cancer.In the fall of last year, he started having really serious infections that brought him repeatedly to (b)(6).The most serious was sepsis and they thought they lost him on that visit.They found out about the recall of the alcohol wipes and was astounded.At one point she was giving him antibiotics through his picc line 5x a day plus his tpn.Faithfully she would use our wipes.When they stopped using the wipes, the infections also stopped.The customer stated that their time with her husband is so precious.He had been able to work remotely until the constant hospitalizations made it impossible! she was unable to work, his twin sister as well and her daughter has had to put her life on hold repeatedly to watch their household while they were hospitalized.What was taken from them cannot be measured.She stated that our company should be ashamed for the main audience being affected by this being those with compromised immune systems.There was paperwork sent with their supplies but ironically, they were at an emergency trip to the hospital and missed it.And how did it take so long when the initial distribution was in september and they only just found out about it.This should have been brought to their attention in a major way.This has put them through ¿profanfinty.Additionally, information received on 23apr2026 stated that their hospitals stays at (b)(6) were: (b)(6) 2025, (b)(6) 2026.On (b)(6) 2026 started off in icu.There were surrounding days at their local hospital in concord nh before they were able to get a bed at (b)(6).Additionally, the customer stated that prior to (b)(6) 2025, the patient had been feeling good and his cancer had not progressed.They stopped using the wipes when their daughter told them about the recall that she had heard about on tiktok and then researched further.The patient has not had another infection since they stopped using the wipes.
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 ; 5082163840
• MDR Report Key: 25179099
• Report Number: 1423537-2026-00157
• Device Sequence Number: 13369016
• Product Code: LKB
• UDI-Device Identifier: 10192253046205
• UDI-Public: (01)10192253046205(10)25K005762
• Combination Product (Y/N): N
• Initial Reporter State: NH
• 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
• 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
• Device Lot Number: 25K005762
• 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: 04/21/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/14/2026
• 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
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male