BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WASH BASK FULL SIZE 1/1 F/TRS

    MDR report key: 3193219 · Received June 27, 2013

    Report

    Report Number
    8030965-2013-03850
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Report Date
    January 20, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    FSM
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. (B)(6). A REVIEW OF THE DHR FOR THIS LOT HAS BEEN REQUESTED. THE EXAMINATION OF THE QUERIED WASHING BASKET HAS REVEALED THAT CORROSION TRACES APPEAR AT THREE DIFFERENT LOCATIONS OF THE HOLDING BRACKETS. THE VISIBLE TRACES CAN BE REMOVED EASILY BY MECHANICAL MEANS. IT HAS THEREFORE BECOME CLEAR THAT THIS IS AN ACCUMULATION OF CONTACT CORROSION. NO PRODUCT FAULT WAS ESTABLISHED. PER INVESTIGATION REPORT, COMPLAINT WAS CLASSIFIED INVALID.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE FULL SIZE WASHING BASKET WAS RUSTY. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292441 WASH BASK FULL SIZE 1/1 F/TRS FSM SYNTHES GMBH 1179039

    Patients

    Seq Age Sex Outcome Treatment
    1