BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NO DEVICE

    MDR report key: 5719974 · Received June 13, 2016

    Report

    Report Number
    8020862-2016-00033
    Event Type
    Injury
    Date Received
    June 13, 2016
    Date of Event
    May 22, 2016
    Report Date
    May 23, 2016
    Manufacturer
    ALLERGAN (MEDFORD)
    Product Code
    OXF
    PMA / PMN Number
    -
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED. THEREFORE, NO ANALYSIS OR TESTING HAS BEEN DONE. THE EVENT OF INADEQUATE TISSUE INGROWTH IS A PHYSIOLOGICAL COMPLICATION AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THIS EVENT. FURTHER INFORMATION FROM THE REPORTER REGARDING EVENT, PRODUCT, OR PATIENT DETAILS HAS BEEN REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    INVESTIGATION HAS DETERMINED THAT THE INFORMATION SUBMITTED IN MEDWATCH REPORT 8020862-2016-00032 WAS DUPLICATED IN THIS REPORT. ALL ADDITIONAL INFORMATION REGARDING THIS DEVICE WILL BE SUBMITTED UNDER THIS REPORT NUMBER 8020862-2016-00032.

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTED SERI SURGICAL SCAFFOLD WAS PLACED IN THE RIGHT BREAST DURING MASTOPEXY ON (B)(6) 2014. POST-IMPLANTATION, THE DEVICE "DID NOT ABSORB", AND WAS REMOVED ON (B)(6) 2016.

    Description of Event or Problem · 1

    INVESTIGATION HAS DETERMINED THAT THE INFORMATION SUBMITTED IN MEDWATCH REPORT 8020862-2016-00032 WAS DUPLICATED IN THIS REPORT. ALL ADDITIONAL INFORMATION REGARDING THIS DEVICE WILL BE SUBMITTED UNDER REPORT NUMBER 8020862-2016-00032.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    375101 NO DEVICE - OXF ALLERGAN (MEDFORD) NI

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention