BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VASHE

    MDR report key: 20420125 · Received October 9, 2024

    Report

    Report Number
    MW5160932
    Event Type
    Injury
    Date Received
    October 9, 2024
    Date of Event
    September 19, 2024
    Report Date
    October 7, 2024
    Manufacturer
    URGO MEDICAL NORTH AMERICA, LLC
    Product Code
    FRO
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    ON (B)(6) 2024, MY 17 YR OLD SON SAW HIS WOUND CARE DOCTOR AND THEY ORDERED HIM TO USE THE WOUND CARE SOLUTION CALLED VASCHE. THEY ADVISED THAT I PURCHASE IT OTC FROM (B)(6). I PURCHASED IT FROM (B)(6) ON (B)(6) 2024 AND IT WAS DELIVERED (B)(6) 2024. PRIOR TO INTRODUCING THE VASCHE TO THE WOUND, HIS WOUND WAS CLOSING AND HEALING APPROPRIATELY ACCORDING TO HIS PHYSICIAN AND PERSONAL HOME CARE RN. NOTHING IN MY SON'S MEDICAL PROFILE (BLOODWORK, ETC.) INDICATED HE HAS ANY INFECTION PRIOR TO SWITCHING WOUND CARE. MY QUESTION AND CONCERN IS, COULD THE SOLUTION BEEN CONTAMINATED BY EITHER THE SELLER OR (B)(6) PERSONAL PRIOR TO DELIVERY TO MY HOME? I AM UNABLE TO PROVIDE MEDICAL RECORDS AS WE ARE STILL HOSPITALIZED AS OF THE DATE OF THIS WRITING. FOOT WOUND. WE HAVE BEEN HOSPITALIZED AT (B)(6) HOSPITAL IN (B)(6) SINCE (B)(6) 2024. MY NAME IS (B)(6), MY CONTACT INFORMATION IS (B)(6). EMAIL ADDRESS IS (B)(6). MY HOME ADDRESS IS (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2568735 VASHE DRESSING, WOUND, DRUG FRO URGO MEDICAL NORTH AMERICA, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Male Other| H| R BACLOFEN.| GABAPENTIN.| LION'S MANE.| NEUROPATHY SUPPORT.| TYLENOL.