BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT

    MDR report key: 8915846 · Received August 21, 2019

    Report

    Report Number
    2210968-2019-85937
    Event Type
    Injury
    Date Received
    August 21, 2019
    Report Date
    July 29, 2019
    Manufacturer
    ETHICON INC.
    Product Code
    NEW
    PMA / PMN Number
    N18331
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT IS RELATED TO A JOURNAL ARTICLE, THEREFORE NO PRODUCT WILL BE RETURNED FOR ANALYSIS AND THE BATCH HISTORY RECORDS CANNOT BE REVIEWED AS THE LOT NUMBER HAS NOT BEEN PROVIDED. CITATION: J. OF AMBULATORY SURGERY 12 (2006) 125¿129; DOI:10.1016/J.AMBSUR.2005.09.004. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: "TITLE : GIVE THE PATIENTS THE CHOICE¿THE ¿WALK IN WALK OUT¿ HERNIA CLINIC" AUTHOR : DANIEL R. LEFF , RAJINDER P. BHUTIANI. CITATION: J. OF AMBULATORY SURGERY 12 (2006) 125¿129; DOI:10.1016/J.AMBSUR.2005.09.004. THE AIM OF THIS STUDY WAS TO GIVE THE PATIENTS THE CHOICE TO ORGANIZE THE DATE OF THEIR OWN OPERATION, HAVE THE HERNIA REPAIRED UNDER LOCAL ANAESTHETIC AND MAKE ONLY ONE VISIT TO THE HOSPITAL. A TOTAL OF 82 PATIENTS WITH UNILATERAL PRIMARY REDUCIBLE INGUINAL HERNIAS UNDERWENT INGUINAL HERNIA REPAIR USING THE STANDARD LICHTENSTEIN TENSION FREE MESH REPAIR AND WERE INCLUDED IN THE STUDY. IN THE PROCEDURE, THE PROLENE MESH IS SUTURED TO THE INGUINAL LIGAMENT USING 3/0 PROLENE INTERRUPTED SUTURES APPLIED AT THREE ANCHORING SITES; PUBIC TUBERCLE WITH MESH OVERHANGING IT, A MID-POINT BETWEEN PUBIC TUBERCLE AND INTERNAL RING AND JUST LATERAL TO THE INTERNAL RING ITSELF. THE WOUND IS CLOSED IN LAYERS; THE SKIN IS CLOSED USING A SUBCUTICULAR 4/0 PDS SUTURE. ONE PATIENT DEVELOPED A SUBCUTANEOUS HAEMATOMA, FOLLOWING LOCAL TRAUMA IN THE POST-OPERATIVE PERIOD. THE PATIENT MADE A FULL RECOVERY FOLLOWING DRAINAGE OF THE HAEMATOMA IN THE OUTPATIENT CLINIC. PATIENTS WITH UNILATERAL PRIMARY REDUCIBLE INGUINAL HERNIAS, REGARDLESS OF THEIR ASA STATUS CAN SAFELY HAVE OPEN ¿TENSION FREE¿ MESH REPAIR UNDER LOCAL ANAESTHETIC ON A DATE OF THEIR CHOOSING BY MAKING JUST ONE VISIT TO THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    710072 PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT SUTURE, SURGICAL, ABSORBABLE NEW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention