BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT

    MDR report key: 8850050 · Received August 1, 2019

    Report

    Report Number
    2210968-2019-84996
    Event Type
    Injury
    Date Received
    August 1, 2019
    Report Date
    July 18, 2019
    Manufacturer
    ETHICON INC.
    Product Code
    FTL
    PMA / PMN Number
    K962530
    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: GYNECOL SURG (2010) 7:67¿70 / DOI 10.1007/S10397-008-0442-6. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED IN A JOURNAL ARTICLE TITLE: STRANGULATED SMALL BOWEL THROUGH VAGINAL VAULT RUPTURE: LATE COMPLICATION OF ABDOMINAL SACROCOLPOPEXY. THE PURPOSE OF THIS CASE STUDY WAS TO REVIEW THE RISK FACTORS AND PRECIPITATING CAUSES OF BOWEL EVISCERATION PARTICULARLY AFTER SACROCOLPOPEXY, AND PERI- AND INTRAOPERATIVE PREVENTIVE MEASURES ARE DISCUSSED, AS WELL AS VARIOUS MANAGEMENT MODALITIES. A (B)(6)-YEAR-OLD WOMAN FOUND ¿SOMETHING¿ PROLAPSING FROM HER VAGINA AFTER SHE HAD BLOWN HER NOSE AND FELT SOMETHING ¿GIVE WAY¿ INSIDE. SHE PRESENTED WITH LOWER ABDOMINAL PAIN AND VOMITING. SHE WAS HYPERTENSIVE AND HYPOTHYROID AND WAS UNDERGOING A COURSE OF PALLIATIVE CHEMOTHERAPY. THE PATIENT UNDERGONE OPEN ABDOMINAL SACROCOLPOPEXY FOR VAGINAL VAULT PROLAPSE AND RECURRENT CYSTOCELE. POLYPROPYLENE MESH (ETHICON) WAS SUTURED BY MONOFILAMENT, NON-BRAIDED PERMANENT SUTURE (PROLENE SIZE 0) TO THE VAGINAL VAULT AND WITH TITANIUM SPIRAL STAPLES. THERE WAS AN OBVIOUS HERNIATION OF THE SMALL BOWEL THROUGH THE VAGINA. THE BOWEL WAS MARKEDLY CONGESTED, AND THERE WERE EARLY MUCOSAL ULCERATIONS AND ISCHAEMIC CHANGES AND MUCOSAL NECROSIS. THE PROLAPSED BOWEL WAS WRAPPED WITH WARM MOIST SALINE TOWELS, AND A COURSE OF INTRAVENOUS CO-AMOXICLAV WAS COMMENCED. AN EMERGENCY LAPAROTOMY WAS PERFORMED THOUGH A MIDLINE EXPLORATORY ABDOMINAL INCISION; THE PROLAPSED SMALL BOWEL WAS REDUCED, WITH DIFFICULTY, BY A COMBINED VAGINAL AND ABDOMINAL APPROACH. A REMNANT OF THE MESH, USED FOR THE SACROCOLPOPEXY, WAS FOUND LOOSELY ATTACHED TO THE VAULT OF THE VAGINA, WHICH WAS DISSECTED AND REMOVED. THE VAGINAL TEAR WAS CLOSED WITH INTERRUPTED BRAIDED SYNTHETIC ABSORBABLE POLYGLACTIN VICRYL NO (1) SUTURE. THE POST-OPERATIVE PERIOD WAS UNREMARKABLE, AND SHE WAS DISCHARGED FROM THE HOSPITAL A WEEK LATER. AT 6-WEEK FOLLOW-UP, THE PATIENT WAS SYMPTOMATIC, AND THE ABDOMINAL WOUND WAS FOUND WELL HEALED. VAGINAL RUPTURE AND BOWEL EVISCERATION CAN BE REPAIRED VAGINALLY, ABDOMINALLY OR BY A COMBINED APPROACH. LAPAROSCOPIC MANAGEMENT HAS BEEN DESCRIBED. CONCOMITANT SURGICAL REPAIR OF ASSOCIATED VAGINAL PROLAPSE AND PELVIC FLOOR REPAIR DURING SURGICAL MANAGEMENT OF EVISCERATION HAS BEEN ADVOCATED BY SOME AUTHORS; HOWEVER, OTHERS RECOMMEND DELAYED PELVIC REPAIR AFTER THE PRIMARY TISSUE RUPTURE SITES HAVE HEALED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    646990 PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT MESH, SURGICAL, POLYMERIC FTL ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT