BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDIHONEY TUBE - 3.5 FL OZ W/APPLICATOR - STERILE

    MDR report key: 10988632 · Received December 10, 2020

    Report

    Report Number
    9680091-2020-00016
    Event Type
    Injury
    Date Received
    December 10, 2020
    Report Date
    November 23, 2020
    Manufacturer
    DERMA SCIENCES, INC.
    Product Code
    FRO
    PMA / PMN Number
    K080315
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS - D10, G4, G7, H2, H3, H6, H10. THE MEDIHONEY TUBE WAS NOT RETURNED FOR EVALUATION AND NO LOT NUMBER INFORMATION HAS BEEN PROVIDED; THEREFORE, AN EVALUATION OF THE DEVICE COULD NOT BE PERFORMED, AND MANUFACTURING RECORDS COULD NOT BE REVIEWED. THE CAUSE(S) OF THE DIFFICULTY REPORTED BY THE CUSTOMER COULD NOT BE DETERMINED. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE IN THE FUTURE, THIS COMPLAINT WILL BE REOPENED, AND THE RESPECTIVE EVALUATION PERFORMED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR ISSUES. AT PRESENT, WE CONSIDER THIS COMPLAINT TO BE CLOSED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION RECEIVED: CUSTOMER DESCRIBED THE BURNING SENSATION AS "VERY HOT LIKE FIRE WHEN PUT ON WOUND". IT ALSO CAUSED A "LITTLE BIT OF BLOOD TO SURFACE". WASHED OFF WITH SALINE SOLUTION. USED A COMPETITOR PRODUCT AND WOUND IS GETTING BETTER.

    Description of Event or Problem · 0

    N/A.

    Description of Event or Problem · 0

    N/A.

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A PATIENT REPORTED THE MEDIHONEY BURNED AND STUNG HIS SKIN AFTER APPLIED TO TREAT AN ULCERATED WOUND. NO ADDITIONAL INFORMATION WAS PROVIDED AFTER SEVERAL ATTEMPTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1446255 MEDIHONEY TUBE - 3.5 FL OZ W/APPLICATOR - STERILE MEDIHONEY OTHER FRO DERMA SCIENCES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1