BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOLYSIL CATHETER

    MDR report key: 16894466 · Received May 9, 2023

    Report

    Report Number
    9610711-2023-00077
    Event Type
    Malfunction
    Date Received
    May 9, 2023
    Report Date
    August 1, 2023
    Manufacturer
    COLOPLAST A/S
    Product Code
    EZL
    PMA / PMN Number
    K013174
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    WITHOUT THE BENEFIT OF EXAMINATION AND TESTING, COLOPLAST IS PRECLUDED FROM COMMENTING ON THE CONDITION OF THE DEVICE OR THE CAUSE OF THE OCCURRENCE. 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. LOT NUMBER 8931562.

    Additional Manufacturer Narrative · 0

    WE HAVE BEEN INFORMED ABOUT A DEFECT PRODUCT, CATHETER SNAPPED ON A FOLYSIL SILICONE. AFTER RECEIVING THIS COMPLAINT, WE SEARCHED FOR OTHER COMPLAINTS AND FOUND NONE REGARDING THE LOT NUMBER 8931562. CHECKING THE QUALITY DATABASES DID NOT REVEALED ANY ANOMALY IN RELATION TO THE DESCRIBED DEFECT. WE OBSERVED THAT THE TAP WAS NOT WELL PLACED. IT WAS PLACED ON THE CATHETER TUBE, AND ONTO IFU IT WAS RECOMMENDED TO SECURED THE CATHETER WITH TAPE ON THE CATHETER PART.

    Description of Event or Problem · 0

    ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE SNAPPED. THE DEVICE WAS IN FOR THREE DAYS AND IT SNAPPED. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    582840 FOLYSIL CATHETER CATHETER, RETENTION TYPE, BALLOON EZL COLOPLAST A/S AA71081002

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR Unknown