BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXON SUTURE

    MDR report key: 168004 · Received May 20, 1998

    Report

    Report Number
    2648188-1998-00009
    Event Type
    Injury
    Date Received
    May 20, 1998
    Report Date
    April 21, 1998
    Manufacturer
    SHERWOOD DAVIS AND GECK
    Product Code
    GAO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REFERENCE MFR COMPLAINT# MT1998-4-27-205, 206, 207, 208, 209. EXACT LOT NUMBER WAS UNK. PRODUCT IN STOCK IS AS FOLLOWS: 7764-81, LOTS 954569, 966707; 9269-51, LOT 959276; 9009-53 LOTS 934130, 934204. NO SAMPLES WERE RETURNED. RETENTION SAMPLES WERE EVALUATED. STRAIGHT PULL TESTING & IN VITRO TESTING WERE PERFORMED ON EACH LOT WITH SATISFACTORY RESULTS. REVIEW OF THE LOT HISTORIES WAS UNREMARKABLE. WITHOUT THE ACTUAL SAMPLE WE ARE UNABLE TO DETERMINE A CAUSE FOR THE REPORTED DEHISCENCE.

    Description of Event or Problem · 1

    CUSTOMER REPORTS A 19 DAY OLD BABY UNDERWENT SURGERY FOR CORRECTION OF CONGENITAL PYLORIC STENOSIS AND SUFFERED A DEHISCENCE WITH EVISCERATION OF THE THICK AND THIN INTESTINE. UPON REOPERATION, THE SUTURE WAS FOUND TO BE BROKEN, BUT THE KNOTS WERE INTACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEXON SUTURE Implant SURGICAL SUTURE GAO SHERWOOD DAVIS AND GECK NA SEE H-10

    Patients

    Seq Age Sex Outcome Treatment
    1 19 DAY Required Intervention