BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXI-DAM

    MDR report key: 20263343 · Received September 19, 2024

    Report

    Report Number
    2416455-2024-00004
    Event Type
    Injury
    Date Received
    September 19, 2024
    Date of Event
    August 20, 2024
    Report Date
    December 31, 2024
    Manufacturer
    DENT4YOU AG.
    Product Code
    EIE
    UDI-DI
    07630392901208
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO PRODUCT WAS RETURNED FOR INVESTIGATION. THE DESCRIPTION OF THE COMPLAINT STATES THE PATIENT EXPERIENCED CONTACT DERMATITIS DUE TO USE OF THE NON-LATEX DENTAL DAM. THE DENTAL DAM DID NOT TEAR AND THE PATIENT WAS TREATED WITH TOPICAL MEDICATIONS. H09946 IS MANUFACTURED AS NON-LATEX DENTAL DAM AND STORED IN A LOCATION SEALED AND SEPARATED FROM LATEX DENTAL DAM. AS THE PRODUCT WAS NOT RETURNED, IT COULD NOT BE TESTED FURTHER TO DETERMINE IF THE DENTAL DAM CONTAINED CONTAMINATES RESULTING IN SKIN IRRITATION.

    Description of Event or Problem · 0

    THE CUSTOMER STATED THAT THEY HAD A PATIENT EXPERIENCE CONTACT DERMATITIS DUE TO USE OF THE NON-LATEX DAM. THE REACTION WAS NON-SERIOUS AND WAS CONTROLLED WITH TOPICAL MEDICATIONS WITHOUT ANY FURTHER MEDICAL INTERVENTIONS. THE PRODUCT WAS BEING USED WITH SINGLE TOOTH ISOLATION DURING AN ENDODONTIC PROCEDURE AND THE DENTAL DAM DID NOT TEAR. THE INFORMATION PROVIDED REASONABLY SUGGESTS THAT THE MEDICAL DEVICE "CAUSED OR CONTRIBUTED" TO AN INJURY AS THE PATIENT HAD TO SEEK MEDICAL ATTENTION. FOR THIS REASON, OUT OF AN ABUNDANCE OF CAUTION, AND PER 21 CFR 803, THE EVENT IS REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    242765 FLEXI-DAM DENTAL DAM EIE DENT4YOU AG. J181901 07630392901208

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown