BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MPACT HOODED PE LINER

    MDR report key: 4345602 · Received December 11, 2014

    Report

    Report Number
    3005180920-2014-00180
    Event Type
    Injury
    Date Received
    December 11, 2014
    Manufacturer
    MEDACTA INTERNATIONAL, SA
    Product Code
    LZO
    PMA / PMN Number
    K132879
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DOCUMENT REVIEW: IMPACT HIGHCROSS PE HOODED LINER: REF 01.32.3244HCAT / LOT 134704 ((B)(4) LINERS PRODUCED): ALL PARAMETERS WERE FOUND TO BE IN ACCORDANCE WITH THE SPECIFICATIONS VALID AT THE TIME OF MANUFACTURING, INCLUDING WASHING AND STERILIZATION PROCEDURES. IMPACT TWO HOLES SHELL: REF 01.32.152DH / LOT 133662 (B)(4) SHELLS PRODUCED): ALL PARAMETERS WERE FOUND TO BE IN ACCORDANCE WITH THE SPECIFICATIONS VALID AT THE TIME OF MANUFACTURING, INCLUDING WASHING AND STERILIZATION PROCEDURES. TOTAL OF (B)(4) SHELLS BELONGING TO THIS LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR INCIDENT. FROM THE DATA COLLECTED, THERE ARE NO EVIDENCES THAT THE EVENT IS DEVICE RELATED.

    Description of Event or Problem · 1

    IMP REF# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    803905 MPACT HOODED PE LINER ACETABULAR PE LINER LZO MEDACTA INTERNATIONAL, SA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention