BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN

    MDR report key: 17537307 · Received August 12, 2023

    Report

    Report Number
    MW5144186
    Event Type
    Malfunction
    Date Received
    August 12, 2023
    Date of Event
    October 11, 2011
    Report Date
    November 3, 2011
    Manufacturer
    ALPHA MEDICAL
    Product Code
    DYB
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    ISSUE DESCRIPTION: THE PRODUCT WAS UNPACKED FOR A LEAD. THE SHEATH ADVANCED WITH GUIDE WIRE, HOWEVER, IT GOT STUCK AND WAS UNABLE TO ADVANCE. USED OTHER MANUFACTURE PRODUCT SUCCESSFULLY. EVENT DATE: ON (B)(6) 2011, ALERT DATE: ON (B)(6) 2011, PATIENT STATUS: N/A, PRODUCT STATUS: NO RETURN. HOSPITAL / CLINIC: (B)(6) HOSPITAL, RELATED PRODUCTS: DEVICE: F111/104687, RA:4470/681892 RV:0295/100654. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    785098 UNKNOWN INTRODUCER, CATHETER DYB ALPHA MEDICAL DPX-7G

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown