BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EST+ DRNPRECUTINVISICLR35MM(1X10) NAI

    MDR report key: 7868782 · Received September 12, 2018

    Report

    Report Number
    9618003-2018-01581
    Event Type
    Malfunction
    Date Received
    September 12, 2018
    Manufacturer
    CONVATEC DOMINICAN REPUBLIC INC
    Product Code
    EZQ
    PMA / PMN Number
    UNK
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A REPORTABLE MALFUNCTION. TO DATE NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED EIGHT WAFERS WERE OFF CENTER. NO HARM WAS REPORTED AND NO PHOTO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    708603 EST+ DRNPRECUTINVISICLR35MM(1X10) NAI NOT APPLICABLE EZQ CONVATEC DOMINICAN REPUBLIC INC 421023 8G01142

    Patients

    Seq Age Sex Outcome Treatment
    1