BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILVERCEL® ANTIMICROBIAL ALGINATE DRESSING

    MDR report key: 8526412 · Received April 18, 2019

    Report

    Report Number
    8044178-2019-00001
    Event Type
    Injury
    Date Received
    April 18, 2019
    Report Date
    April 18, 2019
    Manufacturer
    ADVANCED MEDICAL SOLUTIONS LTD
    Product Code
    FRO
    PMA / PMN Number
    K024298
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INSUFFICIENT INFORMATION PROVIDED AND AT THIS TIME WE ARE UNABLE TO CONFIRM IF THE DEVICE CAUSED OR CONTRIBUTED TO A SERIOUS INJURY. IF FURTHER INFORMATION BECOMES AVAILABLE A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    ADVANCED MEDICAL SOLUTIONS LTD (AMS) RECEIVED COMPLAINT ON (B)(6) 2019 FROM THE DISTRIBUTOR ACELITY/KCI. SILVERCEL ANTIMICROBIAL ALGINATE DRESSING WAS ORDERED FROM THE WOUND CARE CLINIC AT (B)(6) HOSPITAL (B)(6) AND PLACED UPON THE PATIENTS WOUND, WHICH WAS A WOUND UNDERNEATH THE SKIN. THE DRESSING HAD BEEN CUT INTO SMALL PIECES AND PUSHED THROUGH THE HOLE WITH AN IV CATHETER STRAW UNDERNEATH THE SKIN. SURGEON RETRIEVED HARD PLASTIC FROM THE HOLE. DUE TO THE ISSUE PATIENT RECEIVED TWO ADDITIONAL SURGERIES. THE COMPLAINT STATED THE EVENT OCCURRED IN THE UNITED STATES. A MOTHER SUBMITTED THE COMPLAINT TO ACELITY/KCI ON (B)(6) 2019 ON BEHALF OF HER CHILD. AMS HAS REQUESTED ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321964 SILVERCEL® ANTIMICROBIAL ALGINATE DRESSING ANTIMICROBIAL ALGINATE DRESSING FRO ADVANCED MEDICAL SOLUTIONS LTD NOT KNOWN NOT KNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R