BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN SURGIPRO MESH

    MDR report key: 6231025 · Received January 6, 2017

    Report

    Report Number
    1219930-2017-00024
    Event Type
    Injury
    Date Received
    January 6, 2017
    Date of Event
    June 10, 2002
    Report Date
    February 22, 2018
    Manufacturer
    COVIDIEN, FORMERLY US SURGICAL A DIVISON
    Product Code
    FTL
    PMA / PMN Number
    K982575
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6). (B)(4).

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4).

    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. PRE-OPERATIVE DIAGNOSIS: POST-HYSTERECTOMY VAULT PROLAPSE; LATENT STRESS INCONTINENCE. POST-OPERATIVE DIAGNOSIS: POST-HYSTERECTOMY VAULT PROLAPSE; LATENT STRESS INCONTINENCE. NAME OF PROCEDURE: ANTERIOR REPAIR; POSTERIOR REPAIR; MODIFIED SUBURETHRAL SLING; SACROSPINOUS VAULT SUSPENSION; CYSTOSCOPY; SURGERY: (B)(6) 2003. PRE AND POST-DIAGNOSIS: EXPOSED MESH; CYSTOCELE. NAME OF PROCEDURE: EXCISION OF EXPOSED MESH; ANTERIOR REPAIR; CYSTOSCOPY. SURGERY: (B)(6) 2003. PRE AND POST-OPERATIVE DIAGNOSIS: EXPOSED VAGINAL MESH. NAME OF PROCEDURE: EXAMINATION UNDER ANESTHESIA (EUA); EXCISION OF MESH; RE-APPROXIMATION OF VAGINAL MUCOSA AND CYSTOSCOPY. SURGERY: (B)(6) 2014. PRE AND POST-OPERATIVE DIAGNOSIS: EXTRUDED URETHRAL MESH. NAME OF PROCEDURE: MESH EXCISION.

    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. PRE-OPERATIVE DIAGNOSIS: POST-HYSTERECTOMY VAULT PROLAPSE; LATENT STRESS INCONTINENCE . POST-OPERATIVE DIAGNOSIS: POST-HYSTERECTOMY VAULT PROLAPSE; LATENT STRESS INCONTINENCE. PROCEDURE PERFORMED: ANTERIOR REPAIR; POSTERIOR REPAIR; MODIFIED SUBURETHRAL SLING; SACROSPINOUS VAULT SUSPENSION; CYSTOSCOPY; INSERTION OF SUPRAPUBIC BONANNO CATHETER. SURGERY: (B)(6) 2003. PREAND POST-DIAGNOSIS: EXPOSED MESH; CYSTOCELE. PROCEDURE PERFORMED : EXCISION OF EXPOSED MESH; ANTERIOR REPAIR; CYSTOSCOPY. SURGERY: (B)(6) 2003. PRE AND POST-OPERATIVE DIAGNOSIS: EXPOSED VAGINAL MESH. PROCEDURE PERFORMED : EXAMINATION UNDER ANESTHESIA (EUA); EXCISION OF MESH; RE-APPROXIMATION OF VAGINAL MUCOSA AND CYSTOSCOPY. SURGERY WAS ON (B)(6) 2014. PRE AND POST-OPERATIVE DIAGNOSIS: EXTRUDED URETHRAL MESH. PROCEDURE PERFORMED : MESH EXCISION. SURGERY: HYSTERECTOMY AND BILATERAL SALPINGO-OOPHORECTOMIES FOR EARLY STAGE CANCER FOLLOWED BY RADIATION AND CHEMOTHERAPY. FROM JUNE 2003 TO SEPTEMBER 2009 PATIENT DEVELOPED EXPOSED MESH, DYSPAREUNIA, NOCTURIA, URGENCY, HARD NODULE ON THE ANTERIOR VAGINAL WALL, OCCASIONALLY LEAK, VOIDING DYSFUNCTION, FREQUENCY, VAGINAL BLEEDING, VAGINAL DISCHARGE, RECURRENT UTI, RECTOCELE, PAIN, BOWEL INCONTINENCE, MIXED INCONTINENCE ¿ STRESS AND URGE, OVERACTIVE BLADDER.

    Description of Event or Problem · 1

    MESH REVISION SURGERY: (B)(6) 2009: UNDERWENT EXCISION OF EXPOSED MESH, ANTERIOR REPAIR, CYSTOSCOPY FOR EXPOSED MESH IN ANTERIOR VAGINAL WALL SECONDARY TO MULTIPLE VAGINAL SURGERIES UNDER GENERAL ANESTHESIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    11829 UNKNOWN SURGIPRO MESH MESH, SURGICAL, POLYMERIC FTL COVIDIEN, FORMERLY US SURGICAL A DIVISON UNK SURGIPRO MESH

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other