BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMOOT ANKLE DISTRACTION STRAP; (041501); STERILE

    MDR report key: 13111872 · Received December 29, 2021

    Report

    Report Number
    1836161-2021-00048
    Event Type
    Malfunction
    Date Received
    December 29, 2021
    Date of Event
    December 1, 2021
    Report Date
    December 2, 2021
    Manufacturer
    ASPEN SURGICAL PRODUCTS, CALEDONIA
    Product Code
    CCX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    NO FURTHER INFORMATION IS AVAILABLE ON THE PRODUCT AT THIS TIME. THE INVESTIGATION IS ONGOING, HOWEVER IF ANY ADDITIONAL RELEVANT INFORMATION IS IDENTIFIED FOLLOWING COMPLETION OF THE INVESTIGATION, THE ADDITIONAL RELEVANT INFORMATION WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. DEVICE NOT RETURNED.

    Description of Event or Problem · 0

    ASPEN SURGICAL RECEIVED A REPORT FROM THE END USER INDICATING THAT DURING USE OF THE PRODUCT, THE STRAP CONNECTING TO THE DEVICE BROKE. NO PATIENT HARM WAS REPORTED. THIS INCIDENT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM UNDER NUMBER (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2013505 SMOOT ANKLE DISTRACTION STRAP; (041501); STERILE PATIENT POSITIONING - KNEE/ANKLE CCX ASPEN SURGICAL PRODUCTS, CALEDONIA 713400 021021

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown