BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILIC FOLEY CATH 5/15ML/5

    MDR report key: 3872757 · Received June 13, 2014

    Report

    Report Number
    9610711-2014-00020
    Event Type
    Injury
    Date Received
    June 13, 2014
    Date of Event
    May 15, 2014
    Report Date
    May 16, 2014
    Manufacturer
    COLOPLAST A/S
    Product Code
    EZL
    PMA / PMN Number
    K013174
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS NOT BEEN RETURNED. 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 THE DEVICE OR ADDITIONAL INFORMATION BE RECEIVED, A FOLLOW UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    PATIENT IDENTIFIER: (B)(6). DATE OF EVENT: (B)(6) 2014. ACCORDING TO THE INFORMATION RECEIVED, A CATHETER WAS INSERTED INTO THE BLADDER BY A CARE GIVER ON (B)(6). IN THE MORNING OF (B)(6) THE PATIENT HAD NOTICED THE CATHETER IS NOT FIXED AS USUAL, THE BALLOON HAD LOST SOME LIQUID AND WAS DEFLATED. THE PATIENT COULD BE SUPPLIED WITH ANOTHER CATHETER SHE HAD IT HOME. SHE DID NOT SUFFER ANY HARM, BECAUSE THE CATHETER DID NOT SLIP OUT OF THE BLADDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350155 SILIC FOLEY CATH 5/15ML/5 SILICONE FOLEY CATHETER EZL COLOPLAST A/S AA61181002 12021364

    Patients

    Seq Age Sex Outcome Treatment
    1 Other