BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRIGARD TOWELS

    MDR report key: 8453817 · Received March 26, 2019

    Report

    Report Number
    2433773-2019-00001
    Event Type
    Injury
    Date Received
    March 26, 2019
    Date of Event
    February 26, 2019
    Report Date
    March 26, 2019
    Manufacturer
    CROSSTEX INTERNATIONAL INC.
    Product Code
    KHR
    PMA / PMN Number
    510K EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    CROSSTEX RECEIVED A REPORT THROUGH DISTRIBUTOR, (B)(4). THE REPORT STATED A FACILITY REPORTED THAT WHILE USING A CROSSTEX DRIGARD TOWEL, THE PATIENT EXPERIENCED AN ALLERGIC REACTION. CROSSTEX FOLLOWED UP WITH THE FACILITY FOR MORE INFORMATION. IT WAS REPORTED THE PATIENT EXPERIENCED SYMPTOMS OF ITCHINESS AND REDNESS ON HER SKIN AT THE CONTACT SITE FOR SEVERAL DAYS. THE USER DID SEEK MEDICAL ATTENTION AND RECEIVED STEROID SHOTS. IT WAS REPORTED THE USER'S CURRENT CONDITION IS FINE. CROSSTEX HAS NOT RECEIVED ANY SIMILAR COMPLAINTS RELATED TO THE DRIGARD TOWEL. THIS COMPLAINT WILL CONTINUE TO BE MONITORED IN THE CROSSTEX COMPLAINT HANDLING SYSTEM.

    Description of Event or Problem · 1

    THE FACILITY REPORTED THAT WHILE USING A CROSSTEX DRIGARD TOWEL, THE PATIENT EXPERIENCED AN ALLERGIC REACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    247420 DRIGARD TOWELS TOWEL KHR CROSSTEX INTERNATIONAL INC. WESCEBL

    Patients

    Seq Age Sex Outcome Treatment
    1 Other