BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OR/GASTRO/DUODENAL

    MDR report key: 3810891 · Received March 26, 2014

    Report

    Report Number
    3005778470-2014-00012
    Event Type
    Malfunction
    Date Received
    March 26, 2014
    Date of Event
    February 28, 2014
    Report Date
    February 28, 2014
    Manufacturer
    UNOMEDICAL S.R.O.
    Product Code
    FPD
    PMA / PMN Number
    K896734
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE INFO PROVIDED THIS EVENT IS DEEMED A REPORTABLE MALFUNCTION. ON (B)(4) 2014 ADD'L INFO WAS REC'D INFORMING THAT THE SAMPLE HAS BEEN USED AND RE-STERILIZED. DEVICE WAS USED ON A PT HOWEVER; NO PHYSICAL HARM TO THE PT WAS REPORTED. REQUEST FOR ADD'L PT/EVENT INFO WAS REQUESTED ON (B)(4) 2014, (B)(4) 2014 AND (B)(4) 2014. NO FURTHER PT/EVENT INFO HAS BEEN PROVIDED TO DATE. SHOULD ADD'L INFO BECOME AVAILABLE, A F/U REPORT WILL BE SUBMITTED. REPORTED TO THE FDA ON (B)(4) 2014. NOTE: THE ACTUAL DATE OF EVENT (B3) IS UNK, SO THE DATE USED WAS THE DATE CONVATEC BECAME AWARE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE MANDARIN IS DIFFICULT TO REMOVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    176605 OR/GASTRO/DUODENAL TUBE, FEEDING FPD UNOMEDICAL S.R.O. 10008182 481793

    Patients

    Seq Age Sex Outcome Treatment
    1