MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; BNDG,ANTIBAC,IRONMAN,1X3.25,6-CLRS,20CT

Catalog Number	CURIM5020V1
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Blister (4537); Skin Inflammation/ Irritation (4545)
Date of Event	08/15/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the customer, within "four hours" of using the product on (b)(6) 2025, their skin "started to boil and blister." the customer stated that they "sought care" on (b)(6) 2025 and were prescribed "steroids" for the "open wound that formed in the shape of that center bandaid pad." no additional information is available at this time.It has been determined that the reported event caused or contributed to serious injury, therefore, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.
Event or Problem Description
According to the customer, within "four hours" of using the product on (b)(6) 2025, their skin "started to boil and blister." the customer stated that they "sought care" on (b)(6) 2025 and were prescribed "steroids" for the "open wound that formed in the shape of that center bandaid pad.".

• Common Device Name: BNDG,ANTIBAC,IRONMAN,1X3.25,6-CLRS,20CT
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: jessica walter ; three lakes drive; northfield, IL 60093
• MDR Report Key: 22947241
• Report Number: 1417592-2025-00441
• Device Sequence Number: 9150945
• Product Code: FRO
• UDI-Device Identifier: 00193489023469
• UDI-Public: 00193489023469
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/02/2025

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 Catalogue Number: CURIM5020V1
• Device Lot Number: 240701
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/15/2025
• Initial Report FDA Received Date: 09/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2024
• 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: 27 YR
• Patient Sex: Male
• Patient Weight: 77 KG