BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NASOPORE

    MDR report key: 2202353 · Received August 5, 2011

    Report

    Report Number
    3004504732-2011-00002
    Event Type
    Injury
    Date Received
    August 5, 2011
    Date of Event
    June 9, 2011
    Report Date
    August 2, 2011
    Manufacturer
    POLYGANICS BV
    Product Code
    LYA
    PMA / PMN Number
    K052099
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCTS HAVE NOT (YET) BEEN RECEIVED FOR INVESTIGATION. IF FURTHER INFO IS OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    OCCURRENCE OF TOXIC SHOCK SYNDROME. PROCEDURE SEPTOPLASTY. SURGERY (B)(6) 2011. PT DISCHARGED FOLLOWING DAY. FORTY EIGHT-HOURS POST-OP, PT ADMITTED WITH ABDOMINAL PAIN, FEVER. TREATED STRAIGHT AWAY FOR TSS. WENT TO THEATRE SAME DAY FOR REMOVAL OF ONE NASOPORE (OTHER PIECE CAME OUT). PT WAS TREATED WITH ANTIBIOTICS AND BECAME STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NASOPORE NASAL DRESSING LYA POLYGANICS BV

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Life Threatening