MAUDE Adverse Event Report: MAR-MED INC. TOURNI-COT - SMALL; DIGIT TOURNIQUET

Model Number	TCS
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Codes	Ischemia (1942); Necrosis (1971); Tissue Breakdown (2681)
Date of Event	08/29/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Mar-med has requested additional information from the user facility regarding their investigation into the adverse event.Mar-med will conduct an investigation into the root causes based on information received.
Event or Problem Description
Patient underwent a surgical procedure.The procedure required the use of a digital tourniquet, which is removed at the end of the operation.The patient underwent the procedure on the identified finger as planned with the tourniquet being utilised as per standard practice.During the procedure, the safety tag was removed from the tourniquet to aid visibility.The procedure was completed and the patient discharged home.Upon review in the outpatients department six days later, the digital tourniquet was noted to have been left in-situ causing the finger to become significantly damaged.This led to the digit being amputated that afternoon.

• Brand Name: TOURNI-COT - SMALL
• Common Device Name: DIGIT TOURNIQUET
• Manufacturer (Section D): MAR-MED INC.; 333 fuller ave ne; grand rapids MI 49503
• Manufacturer (Section G): MAR-MED INC.; 333 fuller ave ne; grand rapids MI 49503
• Manufacturer Contact: joel marogil ; 333 fuller ave ne; grand rapids, MI 49503 ; 6164543000
• MDR Report Key: 23952445
• Report Number: 1832653-2026-00001
• Device Sequence Number: 20819782
• Product Code: GAX
• UDI-Device Identifier: 00855364004030
• UDI-Public: 00855364004030
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K853472
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/02/2026

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: TCS
• Device Catalogue Number: TCS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/03/2025
• Initial Report FDA Received Date: 01/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Disability
• Patient Sex: Unknown