BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUREGRAFT 850 SYSTEM

    MDR report key: 8794513 · Received July 16, 2019

    Report

    Report Number
    3011277972-2019-00002
    Event Type
    Injury
    Date Received
    July 16, 2019
    Report Date
    July 11, 2019
    Manufacturer
    PUREGRAFT LLC
    Product Code
    MUU
    PMA / PMN Number
    K113255
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AFTER INITIAL SUBMISSION, IT WAS IDENTIFIED THAT THE MDR NUMBER WAS INCORRECT. THE MDR NUMBER HAS BEEN CORRECTED AND ACCURATELY REFLECTS: 3011277972-2019-00002.

    Description of Event or Problem · 1

    CLINICIAN REPORTED A CASE OF PATIENT INFECTION FOLLOWING BREAST AUGMENTATION PROCEDURE. THE INCIDENT OCCURRED IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    589688 PUREGRAFT 850 SYSTEM SYSTEM, SUCTION, LIPOPLASTY MUU PUREGRAFT LLC 101-014-02 00052115

    Patients

    Seq Age Sex Outcome Treatment
    1 Other