BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FOLEY CATHETER

    MDR report key: 9991982 · Received April 23, 2020

    Report

    Report Number
    9610711-2020-00013
    Event Type
    Injury
    Date Received
    April 23, 2020
    Report Date
    July 1, 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

    WE RECEIVED 1 USED SAMPLE -AT THE FIRST INSPECTION, WE SEE THE TIP BROKEN WITH BURRS, AND ACCEPTABLE ACCORDING TO OUR SPECIFICATION. THE BURRS ARE OF 1MM AND SOFT. IT IS CONCLUDED THAT THE RISKS IDENTIFIED ARE STILL ACCEPTABLE AND CONSIDERED AS SAFE. 5 SIMILAR CASES WERE FOUND SINCE CE MARKING FOR AA6114 WITH BURR. 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.

    Additional Manufacturer Narrative · 1

    AFTER RECEIVING THIS COMPLAINT, WE SEARCHED FOR OTHER COMPLAINT AND WE DIDN'T FIND OTHER COMPLAINT ON THE LOT NUMBER 7210726. CHECKING THE QUALITY DATABASES REVEALED NO ANOMALY IN CONNECTION WITH THE DESCRIBED DEFECT. UNFORTUNATELY 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. SHOULD ADDITIONAL FACTS PROMPT US TO ALTER OR SUPPLEMENT ANY INFORMATION OR CONCLUSIONS CONTAINED IN THE ORIGINAL MDR OR IN ANY PRIOR SUPPLEMENTAL REPORTS, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    ACCORDING TO THE AVAILABLE INFORMATION, THE CATHETER CAUSED A URETHRAL HEMORRHAGE WHEN IT WAS PULLED, THERE IS A SMALL EDGE IN THE TIP AREA WHICH CAUSED THIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    456630 FOLEY CATHETER FOLEY CATHETER EZL COLOPLAST A/S AA61141002 7210726 03600040127360

    Patients

    Seq Age Sex Outcome Treatment
    1 Other