BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIMASEAL AG+

    MDR report key: 22124904 · Received June 2, 2025

    Report

    Report Number
    8044178-2025-00003
    Event Type
    Malfunction
    Date Received
    June 2, 2025
    Date of Event
    January 29, 2025
    Report Date
    May 28, 2025
    Manufacturer
    ADVANCED MEDICAL SOLUTIONS LTD.
    Product Code
    FRO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THERE HAS BEEN NO CLEAR CAUSE ESTABLISHED FOR THIS ADVERSE EVENT, AS THERE WAS MINIMAL INFORMATION AVAILABLE, DESPITE REPEATED ATTEMPTS TO CONTACT THE INITIAL IMPORTER. THIS IS AN ISOLATED INCIDENT WITH NO CAUSE OR RELATIONSHIP WITH THE DEVICE IN QUESTION.

    Description of Event or Problem · 0

    ON MAY 6, 2025, THE DISTRIBUTOR RECEIVED A REACTION COMPLAINT CONCERNING A PATIENT WHO EXPERIENCED COMPLICATIONS FOLLOWING A LEFT KNEE REPLACEMENT ON (B)(6) 2025. THE PATIENT REPORTED ONGOING ISSUES AT THE SURGICAL SITE, INCLUDING FLUID OOZING AND WHAT WAS DESCRIBED AS A POTENTIAL "CHEMICAL BURN," ALLEGEDLY LINKED TO THE USE OF PRIMASEAL POSTOP DRESSING. ALTHOUGH THE INCIDENT OCCURRED IN (B)(6), THE DISTRIBUTOR WAS ONLY INFORMED OF THE INJURY DETAILS ON (B)(6) 2025, WHEN THE HOSPITAL REPORTED IT. NO LOT NUMBER WAS PROVIDED, LIMITING THE ABILITY TO TRACE THE PRODUCT INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    719277 PRIMASEAL AG+ SURGICAL SILVER POST OPERATIVE DRESSING, FRO ADVANCED MEDICAL SOLUTIONS LTD. MSCPS310

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Other