BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PDS PLATE

    MDR report key: 2113321 · Received June 3, 2011

    Report

    Report Number
    2210968-2011-00722
    Event Type
    Injury
    Date Received
    June 3, 2011
    Report Date
    May 11, 2011
    Manufacturer
    ETHICON INC
    Product Code
    NHB
    PMA / PMN Number
    K092590
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFECTION. CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A SECONDARY SEPTALPLASTY PROCEDURE ON AN UNKNOWN DATE AND THE DEVICE WAS IMPLANTED. FOUR MONTHS AFTER THE PROCEDURE, THE PATIENT EXPERIENCED INFECTION, POSSIBLE FOREIGN BODY REACTION WITH THICKEN SCAR AND NASAL TIP COLLAPSE AFTER AN INITIAL EXCELLENT RESULT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PDS PLATE POLYMER, ABSORBABLE NHB ETHICON INC NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention