BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DOUBLE MOBILITY HC LINER 28/DMF

    MDR report key: 4964031 · Received July 31, 2015

    Report

    Report Number
    3005180920-2015-00172
    Event Type
    Injury
    Date Received
    July 31, 2015
    Report Date
    November 11, 2015
    Manufacturer
    MEDACTA INTERNATIONAL, SA
    Product Code
    MEH
    PMA / PMN Number
    K092265
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON 13 OCTOBER IT WAS FINALLY CONFIRMED THAT THE ITEMS ARE NOT AVAILABLE FOR EVALUATION. ON 13 OCTOBER 2015 IT WAS PREPARED A FINAL REPORT WITH THE INFORMATION ALREADY SUBMITTED IN THE INITIAL REPORT. ON THE SAME DAY IT WAS SENT TO THE INITIAL REPORTER AND THE CASE WAS CLOSED.

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON JULY 31, 2015: LOT 150126: (B)(4) LINERS MANUFACTURED AND RELEASED ON APRIL 14, 2015. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) LINERS OF THE LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED ISSUE. LOT 147336: (B)(4) HEADS MANUFACTURED AND RELEASED ON FEBRUARY 11, 2015. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4)HEADS OF THE LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED ISSUE. ON (B)(4) 2015, WE WERE INFORMED THAT THE PATHOGEN IS AN E. COLI.

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    498866 DOUBLE MOBILITY HC LINER 28/DMF HC PE DOUBLE MOBILITY LINER MEH MEDACTA INTERNATIONAL, SA

    Patients

    Seq Age Sex Outcome Treatment
    1