BEUDAMED
    FDA Adverse Event Summary report: N

    POSISEP X

    MDR report key: 2501989 · Received March 19, 2012

    Report

    Report Number
    2501989
    Date Received
    March 19, 2012
    Date of Event
    March 12, 2012
    Report Date
    March 19, 2012
    Manufacturer
    GYRUS ACMI
    Product Code
    LYA
    Report Source
    User Facility report
    Reporter Location
    UT, US

    Narratives

    Description of Event or Problem · 1

    A TRIAL OF A NEW PRODUCT THAT HAD SHELLFISH INGREDIENTS (INTERNAL NASAL SINUS SURGERY DRESSING/FOAM) WAS APPLIED AFTER THE SURGERY WAS DONE AS PER INSTRUCTIONS FROM THE DOCTOR. NO ONE WAS AWARE THE PRODUCT HAD SHELLFISH PRODUCT UNTIL AFTER THE SURGERY WAS COMPLETED. PATIENT IS ALLERGIC TO SHELLFISH. THE VENDOR, GYRUS ACMI, NOTIFIED DR. AFTER THE SURGERY WAS DONE THAT THE TRIAL PRODUCT HAS SMALL AMOUNTS OF SHELLFISH DERIVATIVE IN IT. DR IMMEDIATELY RETURNED TO O.R. TO REMOVE THE PACKAGING. THE PATIENT HAD NO SYMPTOMS OR SIGNS OF ALLERGIC REACTION DURING HIS STAY. THE PATIENT WAS MONITORED AND OBSERVED PER DOCTOR'S ORDERS THEN DISCHARGED HOME. THIS PACKAGING COMES IN A CONTAINER WITH FIVE INDIVIDUAL PACKS. THE COMPLAINT FROM THE STAFF WAS THEY DID NOT KNOW THE PRODUCT CONTAINED SHELLFISH DERIVATIVES. AFTER CONFERRING WITH THE MANUFACTURER IT WAS DISCOVERED THE PACKAGING DID INDICATE IT HAD SHELLFISH DERIVATIVES, BUT IT IS HARD TO FIND ON THE PACKAGING. THE SUGGESTION IS THIS CAUTION NEEDS TO BE MORE VISUAL.======================MANUFACTURER RESPONSE FOR NASAL PACKING FOAM, POSISEP X (PER SITE REPORTER).======================REPORTED THIS ISSUE TO THE MANUFACTURER THROUGH THE LOCAL SALES REP. WE WERE TOLD HE WILL WRITE UP THE REPORT AND EMAIL A COPY TO OUR FACILITY. NOTHING RECEIVED AT PRESENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POSISEP X NASAL PACKING FOAM LYA GYRUS ACMI * 1110760A

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR