BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRIMAPORE POST-OP DRESSINGS

    MDR report key: 4724915 · Received April 23, 2015

    Report

    Report Number
    8043484-2015-00006
    Event Type
    Injury
    Date Received
    April 23, 2015
    Date of Event
    March 30, 2015
    Report Date
    April 15, 2015
    Manufacturer
    SMITH & NEPHEW MEDICAL LTD.
    Product Code
    KGX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT DEVELOPED CELLULITIS POST-OP RE-DO C6-7 ACDF WHILE USING THE PRIMAPORE PRODUCTS. THE PATIENT'S WOUND ON THE ANTERIOR NECK WAS AFFECTED. PATIENT RECEIVED ORAL ANTIBIOTICS. BASED ON THE INFORMATION PROVIDED, THE PATIENT'S CONDITION HAS IMPROVED. TWO OF 3 REPORTS SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    269882 PRIMAPORE POST-OP DRESSINGS TAPE AND BANDAGE, ADHESIVE KGX SMITH & NEPHEW MEDICAL LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other