BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK SERI SURGICAL SCAFFOLD

    MDR report key: 4101617 · Received August 27, 2014

    Report

    Report Number
    3008374097-2014-00067
    Event Type
    Injury
    Date Received
    August 27, 2014
    Date of Event
    July 28, 2014
    Report Date
    July 28, 2014
    Manufacturer
    ALLERGAN
    Product Code
    OXF
    PMA / PMN Number
    K123128
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FURTHER INFO FROM THE REPORTER REGARDING THE EVENT AND PRODUCT DETAILS HAVE BEEN REQUESTED. NO ADD'L INFO IS AVAILABLE AT THIS TIME. DEVICE REMAINS IMPLANTED. THE EVENT OR SEROMA IS A SURGICAL/PHYSIOLOGICAL COMPLICATION AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THIS EVENT. THESE EVENTS ARE BEING REPORTED BECAUSE MEDICAL INTERVENTION WAS REQUIRED, ALTHOUGH DEVICE-RELATEDNESS HAS NOT BEEN ESTABLISHED.

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTED IMPLANTATION OF SERI DURING AN UNSPECIFIED SURGERY. POST IMPLANT, PT PRESENTED WITH SEROMA, LOCATION UNK. PHYSICIAN PLACED A DRAIN, WHICH HAS BEEN "DRAINING SIGNIFICANTLY SINCE THE SURGERY." NO FURTHER INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    522565 UNK SERI SURGICAL SCAFFOLD OXF ALLERGAN NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention