MAUDE Adverse Event Report: 3M Company 3M¿ Tube Securement Device; Tape And Bandage, Adhesive

Model Number	1500U
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/13/2026
Type of Reportable Event	Serious Injury

• Brand Name: 3M¿ Tube Securement Device
• Common Device Name: Tape And Bandage, Adhesive
• Manufacturer (Section D): 3M Company; 2510 conway ave; st. paul MN 55144
• Manufacturer Contact: yvonne mcmann ; 6203 farinon drive; san antonio, TX 78249 ; +1(210)374-3188
• MDR Report Key: 50724476
• Report Number: 2110898-2026-00063
• Device Sequence Number: 8541824
• Product Code: KGX
• UDI-Device Identifier: 50707387792409
• UDI-Public: 0150707387792409172804181034589L
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: Exempt
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 09/10/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: 1500U
• Device Catalogue Number: 1500U
• Device Lot Number: 34589L
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/13/2026
• Initial Report FDA Received Date: 09/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/19/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 47 YR
• Patient Sex: Female
• Patient Race: White