BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK

    MDR report key: 237498 · Received August 24, 1999

    Report

    Report Number
    237498
    Event Type
    Injury
    Date Received
    August 24, 1999
    Date of Event
    September 18, 1998
    Report Date
    August 19, 1999
    Manufacturer
    UNK
    Product Code
    DTH
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CHILD UNDERWENT CLOSURE OF ATRIAL SEPTAL DEFECT ON 9/9/98 AND POST-OP WAS NOTED TO BE FUSSY WITH POOR APPETITE. EVALUATED BY CARDIOLGOIST WHO DIAGNOSED RESIDUAL ATRIAL-SEPTAL DEFECT. PT RETURNED FOR RE-REPAIR ON 9/19/98 AT WHICH TIME SUTURE FOUND TO HAVE BROKEN IN THE MIDDLE. EVENT NOTED IN REVIEW OF OPERATIVE RECORD RETROSPECTIVELY. ATTEMPTS TO IDENTIFY EXACT TYPE OF SUTURE/COMPANY UNSUCCESSFUL. (CHILD DISCHARGED 9/21/98). POSSIBLE MFRS WOULD BE DEKNETEL OR ETHICON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNK Implant SUTURE DTH UNK UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 14 MO Required Intervention