BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AJUST HELICAL SINGLE-INCISION SLING

    MDR report key: 3150117 · Received May 31, 2013

    Report

    Report Number
    1018233-2013-02316
    Event Type
    Injury
    Date Received
    May 31, 2013
    Date of Event
    May 3, 2013
    Report Date
    May 3, 2013
    Manufacturer
    BARD SHANNON LIMITED
    Product Code
    PAH
    PMA / PMN Number
    K123179
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS NOT RETURNED. THE FINISHED PRODUCT MET ALL SPECIFICATION PRIOR TO BEING RELEASED FOR GENERAL DISTRIBUTION. 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 REACTIONS: "COMPLICATIONS ASSOCIATED WITH THE PROPER IMPLANTATION OF THE ADJUST 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/TOO MUCH TENSION PLACED ON THE IMPLANT. PERFORATIONS OR LACERATIONS OF VESSELS, NERVES, BLADDER, BOWEL, URETHRA, OR ANY VISCERA, WHICH MAY OCCUR DURING THE IMPLANTATION PROCEDURE. 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 AND/OR MUCOSA. INFLAMMATION, SENSITIZATION, PAIN, DYSPAREUNIA, SCARIFICATION, CONTRACTION, DEVICE MIGRATION AND FAILURE OF THE PROCEDURE RESULTING IN RECURRENCE OF INCONTINENCE." (B)(4).

    Description of Event or Problem · 1

    (B)(4). IT WAS REPORTED THAT DURING THE SURGICAL PROCEDURE, THE HANDLE OF THE DEVICE USED TO INSERT THE ADJUST HELICAL SLING BROKE. THE DOCTOR OBTAINED ANOTHER DEVICE FOR USE AND WAS UNSUCCESSFUL IN PLACING THE SLING AS IT FELL OUT. AT THIS TIME, THE DOCTOR RECOGNIZED THAT THE PATIENT'S URETHRA WAS PERFORATED AND THE PROCEDURE WAS ABANDONED. THE PATIENT'S URETHRA WAS REPAIRED AND THE PATIENT WAS SENT HOME WITH AN INDWELLING CATHETER. THE CATHETER IS EXPECTED TO REMAIN IN USE FOR 1-2 WEEKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    240416 AJUST HELICAL SINGLE-INCISION SLING PAH BARD SHANNON LIMITED NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other