BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OBG PRODUCTS MUZZAMMELS EZ-HSG CATHETER

    MDR report key: 1908937 · Received November 17, 2010

    Report

    Report Number
    MW5018301
    Event Type
    Injury
    Date Received
    November 17, 2010
    Date of Event
    November 10, 2010
    Report Date
    November 17, 2010
    Manufacturer
    OBG PRODUCTS
    Product Code
    LKF
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IN OUTPATIENT CLINIC, A PATIENT FOR SIS BECAUSE OF ABNORMAL BLEEDING AND POLYP. AN EZ HSG -THAT HAS AN ATTACHED SPONGE COLLAR- CATHETER WAS PLACED IN THE ENDO CERVICAL CANAL WITHOUT DIFFICULTY. WHEN THE CATHETER WAS WITHDRAWN, THE SPONGE COLLAR WAS NO LONGER PRESENT AT THE END OF THE CATHETER. GENTLE EXPLORATION WITH THE IP OF PACKING FORCEPS FAILED TO IDENTIFY THE RETAINED SPONGE COLLAR. THE MANUFACTURER WAS CALLED, BUT THE SUGGESTIONS OFFERED HAD ALREADY BEEN TRIED. THE PATIENT WAS ADMITTED TO THE HOSPITAL, AND A DILATION AND CURETTAGE PERFORMED USING IV SEDATION AND MORPHINE WAS PERFORMED. THE SPONGE WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OBG PRODUCTS MUZZAMMELS EZ-HSG CATHETER INTRA-UTERINE CATHETER LKF OBG PRODUCTS HZ-HSG CATHETER 071201201

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Other