BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXXCEL SOFT THIN WALL STR 6/10

    MDR report key: 5475419 · Received March 2, 2016

    Report

    Report Number
    2242352-2016-00201
    Event Type
    Malfunction
    Date Received
    March 2, 2016
    Date of Event
    February 1, 2016
    Report Date
    February 3, 2016
    Product Code
    DSY
    PMA / PMN Number
    K962433
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2016 03:21 PM (GMT-5:00) ADDED BY (B)(6) ((B)(4)): AN IMAGE WAS INITIALLY SENT SHOWING THAT THE LABEL ON THE PACKAGING WAS DISTORTED AND UNCLEAR. THE DEVICE HAS NOT YET BEEN RETURNED TO MAQUET CARDIAC SURGERY FOR EVALUATION. WE ARE FOLLOWING UP WITH THE CUSTOMER FOR THE RETURN OF THE DEVICE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF THE DEVICE IS RECEIVED. (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2016 10:37 AM (GMT-5:00) ADDED BY (B)(6) ((B)(4)): CUSTOMER RECEIVED PRODUCT WITH A RUINED LABEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    132242 EXXCEL SOFT THIN WALL STR 6/10 PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER DSY 25109323

    Patients

    Seq Age Sex Outcome Treatment
    1