BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONVEEN OPTIMA 35Ø

    MDR report key: 5112333 · Received September 29, 2015

    Report

    Report Number
    3006606901-2015-00017
    Event Type
    Malfunction
    Date Received
    September 29, 2015
    Date of Event
    August 19, 2015
    Report Date
    September 29, 2015
    Manufacturer
    COLOPLAST A/S
    Product Code
    EXJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    ACCORDING TO THE INFORMATION RECEIVED, WHEN THE PATIENT TRIED "CONVEEN OPTIMA" FOR THE FIRST TIME, HE DID NOT SEEM TO HAVE A PROBLEM WITH THE ADHESIVITY OF THE PRODUCT. HE TRIED 22030 BUT FINALLY OPTED FOR 22035 BECAUSE HE FOUND THE 22030 TOO TIGHT. WHEN HE TRIED TO REMOVE THE URISHEATH, IT WAS IMPOSSIBLE TO DO SO. THE DOCTOR HAD TO COME TO REMOVE THE URISTHEATH WITH SCISSORS AND A PINCET. UNFORTUNATELY, THE URISHEATH WAS STUCK SO MUCH THAT THE SKIN CAME OFF. THIS HAPPENED ON (B)(6). TODAY THE PATIENT IS NOT USING THE URISHEATHS ANYMORE TRYING TO LET HIS SKIN HEAL. AN APPOINTMENT WITH THE REP WAS MADE, UNFORTUNATELY, IT WAS CANCELLED BY THE PATIENT'S SON BECAUSE THE PATIENT WAS TERMINAL - NO FURTHER INFORMATION REGARDING THIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    640777 CONVEEN OPTIMA 35Ø MALE EXTERNAL CATHETER-UROSHEATH EXJ COLOPLAST A/S 2203501017 4722179

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Hospitalization| R