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	Unspecified Infection (1930)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A device history record review could not be conducted because a lot number was not provided.Therefore, a review of the specific manufacturing and inspection records was not possible.However, all product lots are required to meet established acceptance criteria and must successfully pass defined visual and functional inspections prior to release.Samples were provided for evaluation, but the reported issue could not be observed at this time.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.
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Event or Problem Description
On (b)(6) 2026, the customer left a message with the field correction action team stating that she received a letter about her alcohol preps being possibly on the recall and then confirmed that they are because the lot number matches.She stated she got an infection a couple of days after using them which they had to cut her open to drain it.During a call back on (b)(6) 2026, the customer stated that she does immunoglobulin (igg) therapy.She cleaned the injection site with the affected prep pads prior to sticking herself with the needle and not even a day or so later, it became puffy.She stated the injection sites typically get puffy, but this site stayed puffy while the other sites go down.She also stated that the site got streaks of red, was hot and hard like a knot.She called her doctor and did a telehealth visit with urgent care.They gave her antibiotics.The site continued to get worse.She called her immunologist who stated she may need to get the site cut opened for drainage.She went to an urgent care facility, and they cut open the site with a scalpel, and left it open for drainage.She received a 2nd dose of antibiotics.She was required to press on the wound to squeeze out the contents.She reported that she now has a scar at the injection site.About two weeks after this incident, she received the recall notice.Names of the antibiotics was unknown at the time of the phone call but were requested via email along with photos of the injection site.

• 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: 25021766
• Report Number: 1423537-2026-00119
• Device Sequence Number: 9587508
• Product Code: LKB
• UDI-Device Identifier: 10192253046205
• UDI-Public: (01)10192253046205
• Combination Product (Y/N): Y
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/27/2026

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
• Operator of Device: Lay User/Patient
• 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: 04/09/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/28/2026
• Supplement Report FDA Received Date: 05/27/2026
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female