BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    81-082416 OEM FOLEY CATH 16FR 400 MALE

    MDR report key: 311324 · Received December 19, 2000

    Report

    Report Number
    1046367-2000-00036
    Event Type
    Malfunction
    Date Received
    December 19, 2000
    Date of Event
    November 9, 2000
    Report Date
    December 15, 2000
    Manufacturer
    DEROYAL
    Product Code
    KOD
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 81-082416 OEM FOLEY CATH 16FR 400 MALE 7R7 FOLEY CATHETER KOD DEROYAL IR 203179

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention