BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AJUST HELICAL ADJUSTABLE SINGLE-INCISION SLING

    MDR report key: 3231668 · Received July 12, 2013

    Report

    Report Number
    1018233-2013-02814
    Event Type
    Injury
    Date Received
    July 12, 2013
    Report Date
    February 29, 2016
    Manufacturer
    BARD SHANNON LIMITED -3005636544
    Product Code
    FTM
    PMA / PMN Number
    K092607
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS NOT RETURNED. THE LOT NUMBER IS UNKNOWN; THEREFORE, THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. THE INSTRUCTIONS FOR USE WHICH ACCOMPANIES ALL DEVICES CURRENTLY ADDRESSES POTENTIAL RISKS ASSOCIATED WITH SURGICALLY IMPLANTED MATERIALS. THE INSTRUCTIONS FOR USE STATES IN THE ADVERSE EVENTS: "COMPLICATIONS ASSOCIATED WITH THE PROPER IMPLANTATION OF THE AJUST HELICAL SLING SYSTEM MAY INCLUDE, BUT ARE NOT LIMITED TO: POSTOPERATIVE HEMATOMA, SEROMA, ABSCESS OR FISTULA FORMATION, OR SCARRING WHICH MAY OCCUR FOLLOWING THE IMPLANT PROCEDURE. URINARY RETENTION, BLADDER OUTLET OBSTRUCTION, AND OTHER VOIDING DYSFUNCTIONS. THESE CONDITIONS MAY BE ASSOCIATED WITH OVER-CORRECTION/ TYPICALLY TOO MUCH TENSION PLACED ON THE IMPLANT. PERFORATIONS OR LACERATIONS OF VESSELS, NERVES, BLADDER, BOWEL, URETHRA, VAGINA, RECTUM OR ANY VISCERA, WHICH MAY OCCUR DURING THE IMPLANTATION. IRRITATION AT THE OPERATIVE WOUND SITE, WHICH MAY ELICIT A FOREIGN BODY RESPONSE THAT LEADS TO WOUND DEHISCENCE, INFLAMMATION AND/OR INFECTION. EXTRUSION THROUGH VAGINAL EPITHELIUM OR EROSION INTO SURROUNDING VISCERA OR ADJACENT ORGANS. INFLAMMATION, SENSITIZATION, PAIN, DYSPAREUNIA, SCARIFICATION, CONTRACTION, DEVICE MIGRATION AND FAILURE OF THE PROCEDURE RESULTING IN RECURRENCE OF INCONTINENCE." (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4) THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BARD.

    Additional Manufacturer Narrative · 1

    (B)(4). THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BARD.

    Description of Event or Problem · 1

    COMPLAINT #(B)(4). THIS COMPLAINT IS BEING OPENED IN ASSOCIATION WITH THE ALLEGED EVENT FILED BY THE PATIENT'S ATTORNEY IN 1018233-2013-02783. THERE HAVE BEEN NO ALLEGATIONS OF DEFICIENCY OR SERIOUS INJURY AGAINST THIS DEVICE. THIS DEVICE IS LISTED IN THE PATIENT'S OPERATIVE REPORT. ASSOCIATED MDR: 1018233-2013-02783.

    Description of Event or Problem · 1

    PER ADDITIONAL INFORMATION RECEIVED, THE PATIENT HAS EXPERIENCED EXTREME LEAKAGE, SEVERE PAIN AND SOME VAGINAL BLEEDING. IT WAS INDICATED IN THE SUMMARY AND CHRONOLOGY AND CONFIRMED IN MEDICAL RECORDS THAT THE PRODUCT WAS IMPLANTED AND REMOVED ON THE SAME DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323289 AJUST HELICAL ADJUSTABLE SINGLE-INCISION SLING FTM BARD SHANNON LIMITED -3005636544 NA HUWC1514

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention