BEUDAMED
    FDA Adverse Event Injury Summary report: N

    1049092-2018-00287

    MDR report key: 7514784 · Received May 15, 2018

    Report

    Report Number
    1049092-2018-00287
    Event Type
    Injury
    Date Received
    May 15, 2018
    Product Code
    FRO
    Report Source
    Manufacturer report
    Reporter Location
    MT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AQUACEL / AQUACEL AG - SURGICAL DRESSING; DRESSING, WOUND, DRUG; FRO; K091034. BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A SERIOUS INJURY. NO LOT NUMBER IS AVAILABLE. A DETAILED INVESTIGATION OR BATCH REVIEW CANNOT BE CONDUCTED. THEREFORE, THIS EVALUATION WILL BE CLOSED. THIS ISSUE WILL BE MONITORED THROUGH THE POST MARKET PRODUCT MONITORING REVIEW PROCESS. ADDITIONAL INFORMATION HAS BEEN REQUESTED, HOWEVER TO DATE NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. FDA REGISTRATION NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A HIP PATIENT HAD A SEVERE REACTION RESULTING IN MANY SMALL BLISTERS WHICH SUBSEQUENTLY TURNED INTO CELLULITS AND AN (UNKNOWN) INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    359050 FRO

    Patients

    Seq Age Sex Outcome Treatment
    1