BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREEDOM SELF-CATH NELATON CH1

    MDR report key: 5099013 · Received September 23, 2015

    Report

    Report Number
    3005945907-2015-00003
    Event Type
    Malfunction
    Date Received
    September 23, 2015
    Date of Event
    August 24, 2015
    Report Date
    September 23, 2015
    Manufacturer
    COLOPLAST A/S
    Product Code
    EXJ
    UDI-DI
    05708932576314
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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 OCCURENCE. 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, END USER HAS BEEN CATHING SINCE HE WAS (B)(6) AND WHEN HE PUTS THE LUBRICATION ON THE CATH AND INSERTS NOTHING COMES OUT. HE THEN REMOVES THE CATHETER AND THEN REALIZES THERE ARE NO EYELETS. EU HAS ABOUT 50 CATHS THAT DON'T HAVE EYELETS THAT HE HAS USED. END USER GETS THEM FROM J&B AND WILL GET HIS NEXT SHIPMENT THE FIRST OF THE MONTH OF 260 AND CATHS 6-10 TIMES A DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    628190 FREEDOM SELF-CATH NELATON CH1 MALE EXTERNAL CATHETER EXJ COLOPLAST A/S 5045201400 05708932576314

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Required Intervention