BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDLINE SUREPREP WIPE

    MDR report key: 19750034 · Received July 16, 2024

    Report

    Report Number
    3003188818-2024-00001
    Event Type
    Injury
    Date Received
    July 16, 2024
    Date of Event
    May 31, 2024
    Report Date
    July 16, 2024
    Manufacturer
    MEDTRADE PRODUCTS LTD
    Product Code
    KMF
    UDI-DI
    40080196770053
    PMA / PMN Number
    K051082
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ACCORDING TO THE FACILITY ON (B)(6) 2024 THE PATIENT EXPERIENCED A SKIN REACTION RELATED TO THE USE OF THE SUREPREP WIPE. PER THE FACILITY THE SKIN WAS "CLEANSED WITH CHLORAPREP" PRIOR TO APPLICATION AND THE SKIN IRRITATION WAS DESCRIBED AS "RED WELTS-RASH LIKE APPEARANCE WHERE THE SKIN PREP WAS APPLIED". PER THE FACILITY THE PATIENT REQUIRED PRESCRIPTION "BACTROBAN OINTMENT WITH EVERY DRESSING CHANGE" AND THE "RASH IS CLEARING UP". NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME, AND THE FACILITY WAS UNABLE TO STATE THE DEFINITIVE CAUSE OF THE RASH. THE INITIAL IMPORTER / DISTRIBUTOR HAS REQUESTED THE DEVICE FOR EVALUATION. IT HAS BEEN DETERMINED THAT THE REPORTED EVENT CAUSED OR CONTRIBUTE TO SERIOUS INJURY REQUIRING MEDICAL INTERVENTION, THEREFORE THIS MEDWATCH IS BEING FILED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED OR OBTAINED A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 0

    ACCORDING TO THE FACILITY ON (B)(6) 2024 THE PATIENT EXPERIENCED A SKIN REACTION RELATED TO THE USE OF THE SUREPREP WIPE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    714754 MEDLINE SUREPREP WIPE WIPE,1ML,SUREPREP NO-STING,BARRIER,FILM KMF MEDTRADE PRODUCTS LTD FG01227201 58641 40080196770053

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Female Other BACTROBAN AT DRESSING CHANGE| CHLOROPREP PRIOR TO APPLICATION