BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN PROTACK

    MDR report key: 8733305 · Received June 26, 2019

    Report

    Report Number
    2647580-2019-03254
    Event Type
    Injury
    Date Received
    June 26, 2019
    Date of Event
    January 1, 2013
    Report Date
    June 25, 2019
    Manufacturer
    US SURGICAL PUERTO RICO
    Product Code
    GDW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TITLE OF ARTICLE: LAPAROSCOPIC REPAIR OF PRIMARY VENTRAL HERNIAS: A SERIES OF 118 CONSECUTIVE PATIENTS SOURCE: GHERARDI D, VAN STEENBERGHE M, DERREY AS, MALVAUX P, LANDENNE J, HAUTERS P YEAR PUBLISHED: 2013. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO THE LITERATURE SOURCE OF STUDY PERFORMED BETWEEN 2001 AND 2010 BY LAPAROSCOPY. FOLLOWING A LAPAROSCOPIC REPAIR OF PRIMARY VENTRAL HERNIAS (PVH), THERE WERE 6 SEROMAS AMONG WHICH 3 WERE TREATED BY ASPIRATION (GRADE 1 COMPLICATION) AND 1 DIFFUSE HYPODERMITIS WITHOUT COLLECTION THAT WAS TREATED SUCCESSFULLY BY INTRAVENOUS ANTIBIOTIC THERAPY (GRADE 2 COMPLICATION). AT THE SAME OFFICE VISIT, 66 PATIENTS (56%) HAD NO PAIN AT ALL, 45 (38%) COMPLAINED OF MILD PAIN WITHOUT ANY NEED FOR PAINKILLERS AND 7 (6%) STILL SUFFERED HEAVY PAIN REQUIRING ANTALGIC THERAPY. AMONG THOSE 7 PATIENTS, TWO HAD LONG LASTING (> 8 WEEKS) ABDOMINAL PAIN. HOWEVER, NO MESH RELATED COMPLICATION WAS NOTED AND NO MESH HAD TO BE REMOVED. THE RECURRENCE RATE WAS 3% (4/118).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    530576 UNKNOWN PROTACK STAPLE, IMPLANTABLE GDW US SURGICAL PUERTO RICO UNKNOWN PROTACK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other