BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PDS FLEX PLATE

    MDR report key: 2083311 · Received May 10, 2011

    Report

    Report Number
    2210968-2011-00605
    Event Type
    Injury
    Date Received
    May 10, 2011
    Date of Event
    March 14, 2011
    Report Date
    April 12, 2011
    Manufacturer
    ETHICON INC
    Product Code
    NHB
    PMA / PMN Number
    K092590
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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. IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A CLOSED RHINOPLASTY PROCEDURE ON (B)(6) 2011 AND ABSORBABLE MESH WAS USED. THE PATIENT WAS PLACED ON ANTIBIOTICS FOR ONE WEEK AFTER SURGERY. EIGHTEEN DAYS AFTER SURGERY, THE PATIENT DEVELOPED SWELLING AND SIGNS OF INFECTION. THE PATIENT WAS PUT ON AUGMENTIN AND BACTROBAN FOR THREE WEEKS. ON (B)(6) 2011, FOUR WEEKS POSTOPERATIVE, THE SWELLING RECURED AND THE PATIENT WAS PLACED ON LEVOQUIN FOR A WEEK. WHEN THE LEVAQUIN WAS DISCONTINUED, THE SWELLING STARTED AGAIN. THE PATIENT WAS PLACED BACK ON LONG-TERM ANTIBIOTICS. THE SURGEON PLANS TO KEEP THE PATIENT ON THE ANTIBIOTIC FOR APPROXIMATELY ONE MORE MONTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PDS FLEX PLATE POLYMER, ABSORBABLE NHB ETHICON INC NA CJ9JLZZ0

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Required Intervention