MAUDE Adverse Event Report: Medline Industries, LP Medline; TAPE,RETENTION,DRESSING,MEDFIX,6"X11YD

Catalog Number	MSC4006
Medical Device Problem Codes	Appropriate Device Problem Term/Code Not Available (3191); Adhesive Too Strong (4071)
Health Effect - Clinical Code	Skin Tears (2516)
Date of Event	07/20/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the customer stated the tape "feels heavy" and described it as "similar to painters tape.".
Additional Manufacturer Narrative
It was reported that the customer stated the tape "feels heavy" and described it as "similar to painters tape." the customer stated that on three separate occasions (b)(6) 2026), removal of the tape from the skin caused a minor skin tear.No medical intervention was needed for the reported skin tears.There were no reports of death, serious injury, medical intervention, or follow-up care.It has been determined that the event did not involve a death or serious injury; however, it meets the definition of a reportable malfunction, as recurrence of the malfunction 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: Medline
• Common Device Name: TAPE,RETENTION,DRESSING,MEDFIX,6"X11YD
• 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: 50506120
• Report Number: 1417592-2026-09352
• Device Sequence Number: 10087798
• Product Code: KGX
• UDI-Device Identifier: 10080196669547
• UDI-Public: 10080196669547
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• 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): 08/28/2026

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: MSC4006
• Device Lot Number: 87525120047
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/06/2026
• Initial Report FDA Received Date: 08/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/25/2025
• 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: 39 YR
• Patient Sex: Female
• Patient Weight: 225 LB