BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN PROTACK

    MDR report key: 8261536 · Received January 18, 2019

    Report

    Report Number
    2647580-2019-00368
    Event Type
    Injury
    Date Received
    January 18, 2019
    Date of Event
    November 1, 2018
    Report Date
    January 18, 2019
    Manufacturer
    US SURGICAL PUERTO RICO
    Product Code
    GDW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TITLE: LAPAROSCOPIC BILATERAL CERVICOSACROPEXY AND VAGINOSACROPEXY: NEW SURGICAL TREATMENT OPTION IN WOMEN WITH PELVIC ORGAN PROLAPSE AND URINARY INCONTINENCE. SOURCE: JOURNAL OF ENDOUROLOGY, VOLUME 32, 2018 (728-735) ARTICLE NUMBER: 11. DATE OF PUBLICATION: NOVEMBER2018. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO LITERATURE STUDY, JOURNAL OF ENDOUROLOGY VOLUME 32, NUMBER 11, NOVEMBER 2018, BY SOKOL REXHEPI, MD, ENTELA REXHEPI, MD, MARTIN STUMM, MD, PETER MALLMANN, MD, PHD, AND SEBASTIAN LUDWIG, MD. THE LITERATURE ARTICLE REVIEWS SURGICAL TECHNIQUE FOR TREATMENT OF APICAL PROLAPSE WITH URINARY INCONTINENCE, AFTER UNDERGOING LAPAROSCOPIC BILATERAL SACROCOLPOPEXY, IT WAS REPORTED IN THE ARTICLE THAT OUT OF 120, TOTAL OF 6 PATIENTS HAD THE FOLLOWING COMPLICATIONS AND WERE REPORTED: BLADDER INJURY (1), BOWEL PERFORATION (1), APICAL PROLAPSE (4). PATIENTS HAD TO BE REOPERATED TO RESOLVE THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54759 UNKNOWN PROTACK STAPLE, IMPLANTABLE GDW US SURGICAL PUERTO RICO UNKNOWN PROTACK

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention