BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AJUST ADJUSTABLE SINGLE INCISION SLING

    MDR report key: 3505727 · Received November 22, 2013

    Report

    Report Number
    1018233-2013-09525
    Event Type
    Injury
    Date Received
    November 22, 2013
    Report Date
    October 10, 2013
    Manufacturer
    BARD SHANNON LIMITED
    Product Code
    PAH
    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 (IFU) WHICH ACCOMPANIES ALL DEVICES CURRENTLY ADDRESSES POTENTIAL RISKS ASSOCIATED WITH SURGICALLY IMPLANTED MATERIALS. (B)(4).

    Additional Manufacturer Narrative · 1

    THE FINISHED PRODUCT MET ALL SPECIFICATIONS PRIOR TO BEING RELEASED FOR GENERAL DISTRIBUTION. THE INSTRUCTIONS FOR USE WHICH ACCOMPANIES ALL DEVICES CURRENTLY ADDRESSES POTENTIAL RISKS ASSOCIATED WITH SURGICALLY IMPLANTED MATERIALS. SEE SCANNED PAGE.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT'S ATTORNEY THAT AS A RESULT OF HAVING THE PRODUCT IMPLANTED, THE PATIENT HAS EXPERIENCED SERIOUS AND PERMANENT INJURIES, PAIN, DISFIGUREMENT, PHYSICAL IMPAIRMENT, PROGRESSION OF EXISTING CONDITIONS AND HAS REQUIRED AND WILL REQUIRE CONTINUED MEDICAL TREATMENT.

    Description of Event or Problem · 1

    PER ADDITIONAL INFORMATION RECEIVED THE PATIENT HAS UNSPECIFIED URINARY PROBLEMS, UNSPECIFIED BOWEL PROBLEMS, RECURRENCE, DYSPAREUNIA, BLOODY VAGINAL DRAINAGE, NAUSEA, BACK/VAGINAL/PELVIC PAIN, CHRONIC PAIN, DISCOMFORT, STRESS INCONTINENCE, URGE INCONTINENCE, URINE LEAKAGE WITH COUGHING/SNEEZING, URGE INCONTINENCE, ANXIETY, CONSTIPATION, FATIGUE, URETHRAL HYPERMOBILITY, SPLEEN PATHWAY TENDERNESS, SUPRAPUBIC DISCOMFORT (DISCOMFORT), ACHING, BLOOD LOSS, CHEST PAIN, AND REQUIRED ADDITIONAL SURGICAL AND NON-SURGICAL INTERVENTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    608290 AJUST ADJUSTABLE SINGLE INCISION SLING PAH BARD SHANNON LIMITED NA IIUUF2509

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention