BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN SURGIPRO MESH

    MDR report key: 3964893 · Received July 18, 2014

    Report

    Report Number
    1219930-2014-00551
    Event Type
    Injury
    Date Received
    July 18, 2014
    Date of Event
    October 23, 2006
    Report Date
    May 10, 2018
    Manufacturer
    COVIDIEN, FORMERLY US SURGICAL
    Product Code
    FTL
    PMA / PMN Number
    K982575
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER: THE PATIENT ALLEGED INJURY.

    Description of Event or Problem · 1

    THE PATIENT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE RESULTING IN AN UNSPECIFIED ADVERSE OUTCOME. PRODUCT WAS USED FOR THERAPEUTIC TREATMENT. REASON FOR MESH IMPLANTATION: UTEROVAGINAL PROLAPSE, URETHRAL HYPERMOBILITY AND STRESS URINARY INCONTINENCE. PROCEDURE (S) PERFORMED: LAPAROSCOPIC SUPRACERVICAL HYSTERECTOMY, LAPAROSCOPIC SACROCOLOPEXY WITH MESH, LAPAROSCOPIC BURCH COLPOSUSPENSION, LAPAROSCOPIC PARAVAGINAL DEFECT REPAIR AND CYSTOSCOPY. COMPLICATIONS POST-OP INCLUDE PAIN, VAGINITIS, ABNORMAL DISCHARGE, AND MESH EROSION. IN 2009, INTERVENTIONAL SURGERY WAS PERFORMED. PROCEDURE (S) PERFORMED: VAGINOSCOPY, VAGINAL REVISION AND EXCISION OF ERODING SUTURE AND MESH AND LIMITED WATER CYSTOSCOPY. COMPLICATIONS POST SURGIPRO IMPLANTATION: (B)(6) 2009: PERSISTENT VAGINAL DISCHARGE, AND SUSPECTED MESH EROSION 1ST MESH REVISION (SURGIPRO) SURGERY: (B)(6) 2009 ¿ UNDERWENT VAGINOSCOPY, VAGINAL REVISION AND EXCISION OF ERODING SUTURE AND MESH AND LIMITED WATER CYSTOSCOPY FOR PERSISTENT VAGINAL DISCHARGE, AND SUSPECTED MESH EROSION UNDER GENERAL ANESTHESIA FOLLOWING THE MESH REVISION SURGERY, DEVELOPED COMPLICATIONS THAT REQUIRED ADDITIONAL SURGERY. COMPLICATION INCLUDES VAGINAL MESH EROSION, UMBILICAL HERNIA, VAGINAL DISCHARGE, DYSPAREUNIA. 2ND MESH REVISION (SURGIPRO) SURGERY: (B)(6) 2010 ¿ UNDERWENT ROBOTICALLY-ASSISTED LAPAROSCOPIC REVISION OF SACROCOLPOPEXY MESH, VAGINOSCOPY AND LIMITED WATER CYSTOSCOPY UNDER GENERAL ENDOTRACHEAL ANESTHESIA 3RD MESH REVISION (SURGIPRO) SURGERY: (B)(6) 2013 ¿ UNDERWENT LAPAROSCOPIC EXCISION SACRAL COLPOPEXY MESH, RIGHT SALPINGECTOMY, CYSTOSCOPY, AND UMBILICAL HERNIA REPAIR FOR EXPOSED SACRAL COLPOPEXY MESH IN VAGINAL WITH LEUKORRHEA, AND UMBILICAL HERNIA UNDER GENERAL ENDOTRACHEAL ANESTHESIA COMPLICATION OF POST 3RD MESH REVISION SURGERY: (B)(6) 2013 - SOME MILD PAIN AROUND SUPRAPUBIC INCISION, DISCHARGE FROM VAGINA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    423426 UNKNOWN SURGIPRO MESH NONE FTL COVIDIEN, FORMERLY US SURGICAL NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other