BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP IN STYLE (ITEM # UNK)

    MDR report key: 3021176 · Received March 21, 2013

    Report

    Report Number
    1419937-2013-00165
    Event Type
    Malfunction
    Date Received
    March 21, 2013
    Date of Event
    February 22, 2013
    Report Date
    February 22, 2013
    Product Code
    HGX
    PMA / PMN Number
    K031614
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CONTACT WAS NOT MADE WITH THE CUSTOMER TO OBTAIN ADD'L INFO REGARDING THE EVENT. SHOULD ADD'L INFO OR THE ORIGINAL PRODUCT BE RECEIVED, RESULTING IN NEW, CHANGED, OR CORRECTED INFO, A F/U REPORT WILL BE FILLED AT THAT TIME. THE PRODUCT INVOLVED IN THE COMPLAINT WAS NOT RETURNED FOR EVAL/INVESTIGATION AT THIS TIME. THEREFORE, NO CONCLUSIONS CAN BE MADE AS TO THE CAUSE OF THE EVENT. THIS PRODUCT WAS RELEASED AS A RESULT OF CAPA (B)(4) WHICH WAS INITIATED FOR PUMP IN STYLE TRANSFORMER OVERHEATING/MELTING ISSUES FOR WHICH A FIELD ACTION SAFETY NOTIFICATION WAS INITIATED ON 04/04/2011. COMPLAINTS AGAINST THIS PRODUCT ARE CURRENTLY BEING INVESTIGATED (B)(4) IN ORDER TO DETERMINE ROOT CAUSE AND WILL CONTINUE TO BE MONITORED.

    Description of Event or Problem · 1

    CUSTOMER CALLED INTO CUSTOMER SERVICE AND STATED THE TRANSFORMER FOR HER PUMP IN STYLE BREAST PUMP WAS CRACKED IN HER HAND AND SHE CAN SEE INSIDE IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    118812 PUMP IN STYLE (ITEM # UNK) NONE HGX 57XXX(UNK)/9207010 REV M - 1212

    Patients

    Seq Age Sex Outcome Treatment
    1