MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP CURAD; DT,CURAD,BANDAGE, PLASTIC,2"X4",10CT

Catalog Number	CURDT47437RB
Medical Device Problem Codes	Difficult to Remove (1528); Adhesive Too Strong (4071)
Health Effect - Clinical Codes	Erythema (1840); Skin Inflammation/ Irritation (4545)
Date of Event	03/26/2026
Type of Reportable Event	Malfunction
Event or Problem Description
According to the customer, the adhesive on the device was "very strong" and the user "had to pull gently on the sides [of the bandage] because [the bandage] really stuck" to the skin.The customer reported that "pulling hard" on the device left a "red mark" on the skin that resolved without medical attention.
Additional Manufacturer Narrative
According to the customer, the adhesive on the device was "very strong" and the user "had to pull gently on the sides [of the bandage] because [the bandage] really stuck" to the skin.The customer reported that "pulling hard" on the device left a "red mark" on the skin that resolved without medical attention.The customer reported there was no serious injury, medical intervention, or follow-up care required related to the reported incident.No additional information is available at this time.It has been determined that the reported event could cause or contribute to serious injury if it were to occur again.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.

• Brand Name: CURAD
• Common Device Name: DT,CURAD,BANDAGE, PLASTIC,2"X4",10CT
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093 2753
• Manufacturer Contact: jessica walter ; three lakes drive; northfield, IL 60093
• MDR Report Key: 24866084
• Report Number: 1417592-2026-00431
• Device Sequence Number: 13071285
• Product Code: KGX
• UDI-Device Identifier: 00080196303048
• UDI-Public: 00080196303048
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: N/A
• 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): 04/13/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Catalogue Number: CURDT47437RB
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/26/2026
• Initial Report FDA Received Date: 04/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Patient Sex: Female