MAUDE Adverse Event Report: Medline Industries, LP Curad; BNDG,ANTIBAC,VARIETY PACK,50CT

Catalog Number	CURIM1850V1
Medical Device Problem Code	Biocompatibility (2886)
Health Effect - Clinical Codes	Pain (1994); Skin Discoloration (2074); Caustic/Chemical Burns (2549); Blister (4537)
Date of Event	07/21/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that "my son had a red splotchy spot on his arm so i placed a curad bandage on the area before he went to daycare.".
Additional Manufacturer Narrative
It was reported that "my son had a red splotchy spot on his arm so i placed a curad bandage on the area before he went to daycare." the reporter stated that "later that day i took the bandage off to give him a bath and his skin where the gauze of the bandage was, was burnt to a crisp, he had several blisters all over and his skin was almost black." the reporter further stated, "after i saw this i immediately took my son out of the bath and took him to the emergency room.They evaluated him and diagnosed him with a chemical burn due to the active ingredient in the bandages." the reporter alleged that "the chemical in the bandage (benzalkonium chloride) caused a chemical burn to my sons skin." additional follow-up treatment was reported, stating "i had to follow-up with his primary care provider who prescribed him an antibiotic ointment and a steroid to reduce inflammation of the burn." at the time of reporting, the patient was reported to be "still very blistered and is having to avoid touching the area due to pain." it has been determined that though the event did not involve a death or serious injury, recurrence could cause or contribute to death or serious injury.Based on the information reviewed, this is a reportable event as defined under 21 cfr 803.3.

• Brand Name: Curad
• Common Device Name: BNDG,ANTIBAC,VARIETY PACK,50CT
• Manufacturer (Section D): Medline Industries, LP; three lakes dr; northfield IL 60093
• Manufacturer Contact: gavin-ainsley nadong ; three lakes dr; northfield, IL 60093
• MDR Report Key: 50242722
• Report Number: 1417592-2026-08746
• Device Sequence Number: 18709085
• Product Code: FRO
• UDI-Device Identifier: 00193489023421
• UDI-Public: 00193489023421
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K113583
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Type of Report: Initial
• Report Date (Section B): 08/13/2026

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?: Yes
• Operator of Device: Lay User/Patient
• Device Catalogue Number: CURIM1850V1
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/27/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/21/2026
• Initial Report FDA Received Date: 08/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 3 YR
• Patient Sex: Male
• Patient Weight: 38 LB
• Patient Race: Black Or African American, White