BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COOK SILICONE BALLOON HYSTEROSALPINGOGRAPHY INJECTION CATHETER

    MDR report key: 8133234 · Received December 5, 2018

    Report

    Report Number
    1820334-2018-03631
    Event Type
    Malfunction
    Date Received
    December 5, 2018
    Report Date
    December 5, 2018
    Manufacturer
    COOK INC
    Product Code
    HES
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MDR IS BEING FILED AFTER THE ASSOCIATED COMPLAINT WAS REVIEWED UNDER REMEDIATION PROTOCOL CAP(B)(4), COMPLAINT/MDR RETROSPECTIVE REVIEW AND REMEDIATION AND REASSESSED AS REPORTABLE. ADDITIONAL COMPLAINT INVESTIGATION AND RECORD REMEDIATION WAS NOT PERFORMED. LOT NUMBERS FOR THE PRODUCTS USED ARE BELIEVED TO BE 6071050 AND 6044939.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE SALINE INFUSION SONOHYSTEROGRAPHY (SIS) PROCEDURE, THE SILICONE HYSTEROSALPINGOGRAPHY INJECTION CATHETER BALLOON WOULD NOT DEFLATE WHEN INSIDE THE PATIENT. THE USER HAD TO FORCEFULLY PULL TO REMOVE THE BALLOON FROM THE CERVIX CAUSING PAIN TO THE PATIENT. THERE WERE NO OTHER ADVERSE EFFECTS REPORTED DUE TO THE EVENT AND NO REPORT OF AN ADDITIONAL PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    972362 COOK SILICONE BALLOON HYSTEROSALPINGOGRAPHY INJECTION CATHETER HES INSUFFLATOR-CARBON DIOXIDE, URETOTUBAL (AND ACCESSORIES) HES COOK INC NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1