BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULAB SYSTEMS USMILE ALIGNER

    MDR report key: 17557479 · Received August 16, 2023

    Report

    Report Number
    3017155477-2023-00006
    Event Type
    Injury
    Date Received
    August 16, 2023
    Date of Event
    July 18, 2023
    Report Date
    August 7, 2023
    Manufacturer
    ULAB SYSTEMS
    Product Code
    NXC
    UDI-DI
    00860002380056
    PMA / PMN Number
    K192596N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    WHO: THE DOCTORS OFFICE CALLED STATING THAT THE PATIENT HAD A POTENTIAL ALLERGIC REACTION DURING TREATMENT WITH THE USMILE ALIGNER. WHAT: THE PATIENT HAD A POTENTIAL ALLERGIC REACTION TO THE ZENDURA MATERIAL USED TO MANUFACTURE THE USMILE ALIGNER. WHEN: (B)(6) 2023. WHERE: THIS DOCTOR'S OFFICE NOTIFIED CLIENT SERVICES VIA A PHONE CALL THAT THEIR PATIENT HAD AN ALLERGIC REACTION TO THE ZENDURA MATERIAL WHY: CLIENT SERVICES REPLIED VIA EMAIL TO THE DOCTOR'S OFFICE AND PROVIDED THE MSDS SHEET FOR THE ZENDURA A AND FLX MATERIALS WHICH IS USED TO MANUFACTURER THE USMILE ALIGNERS. CLIENT SERVICES ALSO ASKED THE DOCTOR OFFICE IF THE PATIENT HAD ANY KNOWN ALLERGIES AND THE DOCTOR'S OFFICE REPLIED: PENDING RESPONSE. CONCLUSION: THE CAUSE OF THE PATIENT'S ALLERGIC REACTION IS UNDETERMINED. IT IS NOT KNOWN IF THE ALIGNER MATERIAL (ZENDURA FLX) OR OTHER MATERIALS USED DURING THE TREATMENT (ADHESIVES/ATTACHMENT BONDING/LATEX) CAUSED THE PATIENT'S ALLERGIC REACTION. PENDING RECEIPT OF THE PRODUCT PER RMA-0568 AND EVALUATION BY THE QUALITY ENGINEER. NO MOVEMENT AS OF (B)(6) 2023 (LABEL GENERATED ON (B)(6) 2023). ULAB SYSTEMS REPORTED THIS ALLERGIC REACTION AS AN EMDR THROUGH OUR WEBTRADER PRODUCTION ACCOUNT, ON (B)(6) 2023.

    Description of Event or Problem · 0

    WHO: THE DOCTORS OFFICE CALLED STATING THAT THE PATIENT HAD A POTENTIAL ALLERGIC REACTION DURING TREATMENT WITH THE USMILE ALIGNER. WHAT: THE PATIENT HAD A POTENTIAL ALLERGIC REACTION TO THE ZENDURA MATERIAL USED TO MANUFACTURE THE USMILE ALIGNER. WHEN: (B)(6) 2023. WHERE: THIS DOCTOR'S OFFICE NOTIFIED CLIENT SERVICES VIA A PHONE CALL THAT THEIR PATIENT HAD AN ALLERGIC REACTION TO THE ZENDURA MATERIAL WHY: CLIENT SERVICES REPLIED VIA EMAIL TO THE DOCTOR'S OFFICE AND PROVIDED THE MSDS SHEET FOR THE ZENDURA A AND FLX MATERIALS WHICH IS USED TO MANUFACTURER THE USMILE ALIGNERS. CLIENT SERVICES ALSO ASKED THE DOCTOR OFFICE IF THE PATIENT HAD ANY KNOWN ALLERGIES AND THE DOCTOR'S OFFICE REPLIED: PENDING RESPONSE. CONCLUSION: THE CAUSE OF THE PATIENT'S ALLERGIC REACTION IS UNDETERMINED. IT IS NOT KNOWN IF THE ALIGNER MATERIAL (ZENDURA FLX) OR OTHER MATERIALS USED DURING THE TREATMENT (ADHESIVES/ATTACHMENT BONDING/LATEX) CAUSED THE PATIENT'S ALLERGIC REACTION. PENDING RECEIPT OF THE PRODUCT PER RMA-0568 AND EVALUATION BY THE QUALITY ENGINEER. NO MOVEMENT AS OF (B)(6) 2023 (LABEL GENERATED ON (B)(6) 2023). ULAB SYSTEMS REPORTED THIS ALLERGIC REACTION AS AN EMDR THROUGH OUR WEBTRADER PRODUCTION ACCOUNT, ON (B)(6) 2023.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1828712 ULAB SYSTEMS USMILE ALIGNER Aligner, sequential NXC ULAB SYSTEMS FG0094 GPY09 00860002380056

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other FG0094,ULAB SYSTEMS USMILE DENTAL ALIGNER KIT