MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP; ADHESIVE PAD,WTRPRF,WHT,8CT,4X4"

Catalog Number	CUR5115
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Rash (2033)
Date of Event	12/01/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the customer "i visited an urgent care facility due to small (1.5 inch round) rashes on posterior left shin and left side hip areas.".
Additional Manufacturer Narrative
According to the customer "i visited an urgent care facility due to small (1.5 inch round) rashes on posterior left shin and left side hip areas.The physician there prescribed an oral antibiotic and suggested i purchase aquaphor ointment and apply a light coating to the affected areas then cover them with sterile bandages".The adhesive portion of the bandages caused an extremely red area on his skin.It was noticed upon bandage removal, approximately 24 hours after the first application.Ointment and bandage was applied, the customer slept for 8 hours, showered, removed bandage and observed the reaction, a deep red rash in the same size and shape as the adhesive of each bandage.Corticosteroid cream was prescribed to reduce the redness and inflammation of skin surface which had contacted the adhesive surrounding the bandage.The redness and inflammation have largely subsided.A sample is available for evaluation.It has been determined that the reported event could cause or contribute to serious injury if it were to occur.In an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

• Common Device Name: ADHESIVE PAD,WTRPRF,WHT,8CT,4X4"
• Manufacturer (Section D): MEDLINE INDUSTRIES LP; three lakes drive; northfield IL 60093 2753
• Manufacturer Contact: alex mathew ; three lakes drive; northfield, IL 60093-2753 ; 2249317042
• MDR Report Key: 21106432
• Report Number: 1417592-2025-00014
• Device Sequence Number: 15617444
• Product Code: NAC
• UDI-Device Identifier: 00888277317607
• UDI-Public: 00888277317607
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 01/08/2025

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
• Device Catalogue Number: CUR5115
• Device Lot Number: 10322060005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/23/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/11/2024
• Initial Report FDA Received Date: 01/08/2025
• 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: 67 YR
• Patient Sex: Male
• Patient Weight: 127 KG