BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PDS PLATE

    MDR report key: 2132792 · Received June 17, 2011

    Report

    Report Number
    2210968-2011-00794
    Event Type
    Injury
    Date Received
    June 17, 2011
    Report Date
    May 25, 2011
    Manufacturer
    ETHICON
    Product Code
    NHB
    PMA / PMN Number
    K092590
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT THE PATIENT & (B)(4) INFECTION WENT AWAY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY SEPTOPLASTY ON AN UNKNOWN DATE AND AN ABSORBABLE MESH WAS USED. THE PATIENT DEVELOPED AN INFECTION. THE PHYSICIAN STATED HE WAS NOT SURE IF THE INFECTION WAS RELATED TO THE MESH PLATE AND MAY HAVE BEEN SECONDARY TO A SEPTAL HEMATOMA AS HE DRAINED SOME OLD BLOOD FROM BENEATH THE MUCOPERIOSTEAL FLAPS AS PART OF THE TREATMENT. THE PHYSICIAN USED A THIN ABSORBABLE MESH WITH CARTILAGE GRAFTS SUTURED TO THE PLATE ON ONE SIDE ONLY. THE PHYSICIAN CULTURED AN ASPIRATE OF THE FLUID COLLECTION, (B)(6). HE HAD PUT THE PATIENT EMPIRICALLY ON (B)(6) BUT AT THAT POINT OF KNOWN SENSITIVITY, THE PATIENT WAS SWITCHED TO (B)(6). THE PATIENT HAS IMPROVED CLINICALLY AND THE PHYSICIAN EXPECTS HE WILL GET A GOOD RESULT. THE PHYSICIAN STATED THE PATIENT IS BIPOLAR AND QUESTIONED THE PATIENT AND (B)(4) COMPLIANCE WITH HIS ROUTINE POST OPERATIVE ANTIBIOTIC COVERAGE PRIOR TO HIS RETURN WITH THE INFECTION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention