BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FEMSOFTINSERT

    MDR report key: 4539093 · Received February 20, 2015

    Report

    Report Number
    1018233-2015-00052
    Event Type
    Injury
    Date Received
    February 20, 2015
    Date of Event
    January 26, 2015
    Report Date
    January 29, 2015
    Manufacturer
    ROCHESTER MEDICAL CORP.
    Product Code
    OCK
    PMA / PMN Number
    P990002
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVALUATION, HOWEVER A PHOTO OF THE DEVICE FOLLOWING REMOVAL FROM THE PATIENT WAS MADE AVAILABLE. THE LOT NUMBER IS UNKNOWN; THEREFORE, THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS FOUND INSIDE THE PATIENT'S BLADDER DURING A ROUTINE ULTRASOUND. A PREVIOUS ULTRASOUND IN (B)(6) 2014 DID NOT SHOW THE DEVICE. THE PATIENT HAD EXPERIENCED A UTI AND SOME BLEEDING PRIOR TO DISCOVERY, BUT THE PATIENT AND HER MOTHER HAD BEEN UNAWARE THAT THE DEVICE WAS MISSING UNTIL THE SCAN. THE PATIENT HAD BEEN PRESCRIBED THE DEVICE WAS TREATMENT FOR STRESS URINARY INCONTINENCE, AS THE PATIENT HAS BEEN DIAGNOSED WITH SPINIA BIFIDA WITH NEUROGENIC BLADDER AND BOWEL, AND IS NOT CONFIRMED TO A WHEELCHAIR. THE PATIENT HAS BEEN INSERTING THE DEVICE HERSELF FOR SEVERAL MONTHS, PRIOR TO THIS HER MOTHER HAD BEEN INSERTING THEM FOR HER. THE DEVICE WAS REMOVED FROM THE BLADDER VIA CYSTOSCOPY. A LARGE STONE WAS NOTED ON ONE END. ANTIBIOTICS WERE GIVEN PROPHYLACTICALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124386 FEMSOFTINSERT OCK ROCHESTER MEDICAL CORP. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Required Intervention 4161025 WELLSPECT LOFRIC SENSE CH10| INTERMITTENT CATHETERS