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	Abscess (1690); Dehydration (1807); Fatigue (1849); Ulcer (2274); Swelling/ Edema (4577); Abnormal scarring (4896)
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 she uses webcol wipes for her weekly intramuscular (im) injected medication and to clean her electric razor.She now has a giant abscess, and her face is covered in sores.She has done three rounds of doxycycline, but it always comes back.
Additional Manufacturer Narrative
Section b2: outcomes attributed to adverse event, has been updated.Section b5 has been updated to include additional information received from the customer.Section e1: initial reporter address has been updated.Section h6: health effect ¿ clinical code and health effect ¿ impact code has been updated.
Event or Problem Description
The customer reported that she uses webcol wipes for her weekly intramuscular (im) injected medication and to clean her electric razor.She now has a giant abscess, and her face is covered in sores.She has done three rounds of doxycycline, but it always comes back.Additional information was received from the customer and stated that she was using a new webcol wipe for each injection and razor cleaning, and had never previously experienced skin irritation or reactions to them.However, she developed severe symptoms, starting with facial oozing pus and swollen eyes for a week leading up to her first er visit on (b)(6) 2025.Initially, she noted irritation at the injection site, which seemed to resolve before "resurfacing" as a deep void.Her tissue liquefied, forming a rapidly growing balloon of pus and blood on her hip.This mass, described as a "jiggling water balloon," resulted from several injection sites merging into a large sack.The affected area displayed a range of colors, evolving from bruise-like hues with a "sunset inside" to very yellow, then increasingly red, and eventually yellow again.Black dots appeared as new tissue filled in, with pinpoint openings on the surface revealing narrow black ribbons underneath.These openings, sometimes as large as a quarter or a dime, oozed clear, yellow, or green fluids at various times during tissue regeneration, maintaining a consistent slow drainage throughout.She found that keeping the area covered with vaseline, gauze, and silicone-based adhesive tape provided some relief.She later discovered that due to an undiagnosed connective tissue disorder, standard bandage adhesive caused significant irritation to her skin, eventually finding healqu brand non-woven tape to be suitable.She experienced about two weeks of severe swelling, fatigue, and dehydration before her condition improved.However, symptoms recur whenever she discontinues doxycycline, though not as rapidly or aggressively as when she was using the webcol wipes.The issues, initially concentrated on her chin, quickly spread to her entire face and eyes, becoming systemic.She now suffers from disfigurement and extensive scarring, including keloids, across her body.The customer noted a history of aggressive infections that resolved with antibiotics without recurrence.She feels she has been poorly treated due to the unusual and unknown nature of this particular infection.She also has multiple chemical sensitivity (mcs), which leads her to use extremely neutral and gentle products, none of which were found to cause irritation or infection.She describes herself as meticulously clean and careful about disinfection, using only the simplest, gentlest products available.Her known sensitivities are to harsh chemicals, artificial fragrance, pineapple, and kiwi.She also suggested that a pre-existing skin condition might be relevant to this reaction.
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.Inspection results were within acceptable limits, and no manufacturing or inspection anomalies related to the reported issue were identified.Photos were provided for evaluation, but without physical samples we are unable to observe the reported issue.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
Section d4: lot number and unique identifier (udi) # added.

• 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: 24772252
• Report Number: 1423537-2026-00092
• Device Sequence Number: 14968387
• Product Code: LKB
• UDI-Device Identifier: 10192253046205
• UDI-Public: (01)10192253046205(10)20F099262
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,Followup,Followup
• Report Date (Section B): 05/21/2026

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: 20F099262
• 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; Not provided; Not provided
• Initial Report FDA Received Date: 04/02/2026
• Supplement Report FDA Received Date: 04/29/2026; 05/12/2026; 05/21/2026
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Other
• Patient Sex: Female