BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPROSYN UD 3/0

    MDR report key: 1241707 · Received November 19, 2008

    Report

    Report Number
    1219930-2008-00845
    Event Type
    Injury
    Date Received
    November 19, 2008
    Date of Event
    October 11, 2008
    Report Date
    October 22, 2008
    Manufacturer
    NORTH HAVEN - USS
    Product Code
    GAN
    PMA / PMN Number
    K032586
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CAPROSYN IS A SHORT TERM ABSORBABLE SUTURE, AND ACCORDING TO THE IFU RETAINS 50-60% OF USP STRENGTH AT 5 DAYS AND 20-30% STRENGTH OF USP AT 10 DAYS. IT SHOULD NOT BE USED WHERE EXTENDED APPROXIMATION OF TISSUE IS REQUIRED.

    Description of Event or Problem · 1

    PROCEDURE TYPE: HIP REPLACEMENT. ACCORDING TO THE REPORTER, SEVEN PATIENTS HAD THE SAME REPORTED CONDITION: THERE WAS WOUND DEHISCENCE AT THE SUTURE LINE BETWEEN TWO AND EIGHT DAYS POST-OPERATIVELY. THERE WAS NO SIGN OF THE SUTURE ALONG THE SUBCUTANEOUS LINE AFTER THE DEHISCENCE. THE WOUND HAD INCREASED FLUID AND SWELLING. THE PATIENT'S HOSPITAL STAY WAS EXTENDED, DUE TO THE REPORTED CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPROSYN UD 3/0 SYNTHETIC ABSORBABLE SUTURE GAN NORTH HAVEN - USS A8G1437

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization