BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDICAL UNKNOWN

    MDR report key: 3833130 · Received March 24, 2014

    Report

    Report Number
    3004365956-2014-00142
    Event Type
    Malfunction
    Date Received
    March 24, 2014
    Date of Event
    March 1, 2014
    Report Date
    March 6, 2014
    Manufacturer
    TELEFLEX
    Product Code
    KNX
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY REVIEW (DHR) COULD NOT BE CONDUCTED SINCE NO LOT NUMBER WAS PROVIDED. MFG (WI-DUS-003 REV. 16, WI-DUS-032 REV. 10 AND WI-DUS-033 REV. 11) AND QUALITY INSPECTION FORM (QA-DUS-001/F10 REV. 08) PROCEDURES AND PROCESSES WERE REVIEWED AND SHOWED THAT PROPER CONTROLS WERE IN PLACE TO GUARANTEE THAT ACCEPTABLE PRODUCT IS DELIVERED TO OUR CUSTOMERS. NO CORRECTIVE ACTION CAN BE ESTABLISHED AT THIS MOMENT SINCE THE DEFECTIVE SAMPLE WAS NOT REC'D FOR EVAL. NO CONCLUSION CAN BE ESTABLISHED AT THIS TIME BASED ON THE LACK OF DEFECTIVE OF SAMPLE. IT IS NECESSARY TO HAVE THE PHYSICAL SAMPLE IN ORDER TO PERFORM A PROPER INVESTIGATION. MFR WILL CONTINUE TO TREND RELATING COMPLAINTS.

    Description of Event or Problem · 1

    COMPLAINT ALLEGES: THE COMPLAINANT WAS THE DAUGHTER OF THE END USER. SHE ALLEGES THAT HER FATHER'S BELLY BAG WAS DEFECTIVE. IT LEAKED ON SEVERAL OCCASIONS AND ONE NIGHT, HIS URINE DID NOT EMPTY INTO THE BAG. THE COMPLAINANT WAS UNABLE TO PROVIDE A PRODUCT NUMBER OR LOT NUMBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172425 MEDICAL UNKNOWN BELLY BAG KNX TELEFLEX

    Patients

    Seq Age Sex Outcome Treatment
    1