MAUDE Adverse Event Report: MAR-MED INC. TOURNI-COT - UNIVERSAL

Model Number	TCU
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Device Handling Problem (3265); Unclear Information (4052)
Health Effect - Clinical Code	Tissue Breakdown (2681)
Date of Event	07/01/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
We received a report from the user indicating the problems they experienced.They reported there was a device failure and associated user error.We are currently in the process of reviewing our internal systems to see how to address this event.
Event or Problem Description
Finger tourniquet was left insitu following local anaesthetic procedure.It is unknown whether it was part or the whole device.Details of injury (to patient, carer or healthcare professional): the (b)(6) year old patient's finger had dry gangrene which had to be amputated.Action taken (includes any action by patient, carer or healthcare professional, or by the manufacturer or supplier) device removed from use.

• Brand Name: TOURNI-COT - UNIVERSAL
• Common Device Name: TOURNI-COT - UNIVERSAL
• Manufacturer (Section D): MAR-MED INC.; 333 fuller ave ne; grand rapids MI 49503
• MDR Report Key: 10795761
• Report Number: 1832653-2020-00001
• Device Sequence Number: 19756507
• Product Code: GAX
• UDI-Device Identifier: 00855364004085
• UDI-Public: 00855364004085
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K853472
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Administrator/Supervisor
• Remedial Action: Relabeling,Modification/Adjustment
• Type of Report: Initial
• Report Date (Section B): 10/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/09/2022
• Device Model Number: TCU
• Device Catalogue Number: TCU
• Device Lot Number: 121909-A
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/10/2020
• Initial Report FDA Received Date: 11/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Disability
• Patient Age: 14 YR