BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMOGRAN MATRIX WOUND DRESSING

    MDR report key: 3697693 · Received March 4, 2014

    Report

    Report Number
    3007663067-2014-00001
    Event Type
    Injury
    Date Received
    March 4, 2014
    Date of Event
    August 5, 2010
    Report Date
    February 11, 2014
    Manufacturer
    SYSTAGENIX WOUND MANAGEMENT MANUFACTURING LIMITED
    Product Code
    FRO
    PMA / PMN Number
    K014129
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. DURING INTERROGATION, FOR POST MARKET SURVEILLANCE ACTIVITIES, THE MANUFACTURER BECAME AWARE OF AN ADVERSE EVENT REPORTED BY (B)(4) IN 2010 THAT ALSO MENTIONED THE USE OF PROMOGRAN. THIS IS THE INITIAL AND FINAL REPORT.

    Description of Event or Problem · 1

    PT WENT TO THE EMERGENCY ROOM WITH ANAPHYLACTIC SHOCK SEVERAL HOURS AFTER WOUND CARE NURSE CHANGED THE DRESSING ON A CHRONIC WOUND. THE STEPS TAKEN DURING THE DRESSING CHANGE WAS: RINSED AROUND THE EDGES OF THE WOUND WITH BETADINE, THEN RINSED WITH A WOUND CLEANSER THAT HAS BEEN USED SEVERAL TIMES IN THE PAST, THEN APPLIED A WOUND DRESSING AND COVERED IT WITH A MEPILEX (B)(4). FOUR TO FIVE PIECES OF THE MEPILEX (B)(4)WAS APPLIED. PT HAS NO HISTORY OF SILVER ALLERGY. BASED ON INTERNAL INVESTIGATION, THEY DETERMINED THE ANAPHYLAXIS WAS DUE TO THE BETADINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    130844 PROMOGRAN MATRIX WOUND DRESSING WOUND DRESSING FRO FRO SYSTAGENIX WOUND MANAGEMENT MANUFACTURING LIMITED UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization