BEUDAMED
    FDA Adverse Event Summary report: N

    CORIN BIPOLAR PROSTHESIS

    MDR report key: 2450056 · Received February 9, 2012

    Report

    Report Number
    9614209-2012-00006
    Date Received
    February 9, 2012
    Report Date
    December 13, 2011
    Manufacturer
    CORIN, LTD.
    Product Code
    KWY
    PMA / PMN Number
    K925897
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CAPA COMPLAINT (B)(4). MEDICAL NOTES AND X-RAYS REQUESTED.

    Description of Event or Problem · 1

    REVISION AFTER 3 MONTHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CORIN BIPOLAR PROSTHESIS KWY PROS, HIP, HEMI -, FEMORAL KWY CORIN, LTD. MBRF

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R ASSOCIATED HEAD DEVICE: CAT# 179.048, LOT# IVMI