BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILIC FOLEY CATHETER

    MDR report key: 9945276 · Received April 9, 2020

    Report

    Report Number
    9610711-2020-00012
    Event Type
    Injury
    Date Received
    April 9, 2020
    Report Date
    July 23, 2020
    Manufacturer
    COLOPLAST A/S
    Product Code
    EZL
    UDI-DI
    03600040127360
    PMA / PMN Number
    K013174
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    CHECKING THE QUALITY DATABASES REVEALED NO ANOMALY IN CONNECTION WITH THE DESCRIBED DEFECT. THE PRODUCT REFERENCE AA61141002 LOT NUMBER 6964692 WAS MADE WITH THE INTERMEDIATE PRODUCT AA611480 LOT NUMBER 6708997. 5 SIMILAR CASES WERE FOUND FOR AA6114. NO SAMPLE IS AVAILABLE FROM THE CUSTOMER AND WE CANNOT GO FURTHER THAN THE DOCUMENTARY INVESTIGATION WHICH DIDN'T REVEAL ANY ANOMALY RECORDED DURING PRODUCTION. THE DEVICE CONFORMS ACCORDING TO OUR SPECIFICATIONS. IT IS CONCLUDED THAT THE RISKS IDENTIFIED ARE STILL ACCEPTABLE AND CONSIDERED AS SAFE. OUR CLINICAL ASSESSMENT CONCLUDED : CATHETERIZATION WITH FOLEY CATHETERS IS A COMMON UROLOGICAL PROCEDURE. THIS TYPE OF MEDICAL DEVICE MUST ONLY BE USED BY TRAINED AND EXPERIENCED PROFESSIONALS. THE PROFESSIONALS SHOULD PARTICULARLY CHECK THE CATHETER AND BALLOON (BY INFLATION/DEFLATION) BEFORE USE. SUCH INCIDENT IS POSSIBLY IN FAVOR OF A PRODUCT DEFECT.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED STATED IN THE OPERATION THEATRE, WHEN CATHETER WAS PLACED PRIOR TO THE SURGERY AND WAS REMOVED WHEN THE SURGERY WAS FINISHED. NO CLINICAL CONSEQUENCE FOR THE PATIENT IS REPORTED.

    Additional Manufacturer Narrative · 1

    AFTER RECEIVING THIS COMPLAINT, WE SEARCHED FOR OTHER COMPLAINT AND WE DIDN'T FIND OTHER COMPLAINT ON THE LOT NUMBER 6964692. CHECKING THE QUALITY DATABASES REVEALED NO ANOMALY IN CONNECTION WITH THE DESCRIBED DEFECT. NO SAMPLE IS AVAILABLE FROM THE CUSTOMER AND WE CANNOT GO FURTHER THAN THE DOCUMENTARY INVESTIGATION WHICH DIDN'T REVEAL ANY ANOMALY RECORDED DURING PRODUCTION.

    Description of Event or Problem · 1

    ACCORDING TO THE AVAILABLE INFORMATION, THERE IS A SMALL EDGE IN THE TIP AREA OF THE PRODUCT, WHICH CAUSES AN INJURY IN THE MUCOUS MEMBRANE WHEN THE PRODUCT WAS PULLED, CAUSING URETHRAL BLEEDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    406904 SILIC FOLEY CATHETER FOLEY CATHETER EZL COLOPLAST A/S AA61141002 6964692 03600040127360

    Patients

    Seq Age Sex Outcome Treatment
    1 Other