BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIMASEAL AG+

    MDR report key: 14187699 · Received April 22, 2022

    Report

    Report Number
    8044178-2022-00004
    Event Type
    Malfunction
    Date Received
    April 22, 2022
    Report Date
    April 22, 2022
    Manufacturer
    ADVANCED MEDICAL SOLUTIONS LTD.
    Product Code
    FRO
    PMA / PMN Number
    K180634
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    IN FDA'S MEDICAL DEVICE REPORTING FOR MANUFACTURERS' DOCUMENT ISSUED ON (B)(6) 2016, A "SERIOUS INJURY" IS AN INJURY OR ILLNESS THAT IS LIFE THREATENING, RESULTS IN PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE; OR NECESSITATES MEDICAL OR SURGICAL INTERVENTION TO PRECLUDE PERMANENT DAMAGE TO A BODY STRUCTURE.' IF THIS MALFUNCTION WAS TO RECUR, IN THE WORST CASE, IT COULD LEAD TO AN INFECTION THAT COULD REQUIRE MEDICAL INTERVENTION. THIS MALFUNCTION WILL BE REPORTED AS THE CHANCE OF A DEATH OR SERIOUS INJURY OCCURRING AS A RESULT OF A RECURRENCE OF THE MALFUNCTION IS NOT REMOTE. HOWEVER, THERE WAS NO SERIOUS INJURY ASSOCIATED WITH THIS EVENT.

    Description of Event or Problem · 0

    THE DISTRIBUTOR INITIALLY REPORTED A POST-OPERATIVE INFECTION WITH THE USE OF PRIMASEAL POST-OP DRESSING, WITH POOR ADHERENCE OF THE DRESSING. THE DISTRIBUTOR THEN CLARIFIED THERE WAS NO INFECTION, ONLY A CONCERN ABOUT POSSIBLE INFECTION DUE TO LACK OF ADHESION OF THE DRESSING. THERE ARE 4 DRESSINGS ASSOCIATED WITH THE COMPLAINT. IT IS UNDETERMINED WHETHER THE 4 DRESSINGS RELATED TO 4 DIFFERENT PATIENTS OR 1 PATIENT. THEREFORE AS A PRECAUTIONARY MEASURE THIS EVENT IS BEING REPORTED 4 TIMES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    794610 PRIMASEAL AG+ SURGICAL SILVER POST OPERATIVE DRESSING FRO ADVANCED MEDICAL SOLUTIONS LTD. MSCPS36 W00049133

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other