BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EMA HALF UPPER

    MDR report key: 17656230 · Received August 30, 2023

    Report

    Report Number
    3011649314-2023-00594
    Event Type
    Injury
    Date Received
    August 30, 2023
    Report Date
    December 5, 2023
    Manufacturer
    PRISMATIK DENTALCRAFT, INC.
    Product Code
    LRK
    PMA / PMN Number
    K971794
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HAS NOT BEEN RETURNED. HOWEVER, THE NON-VISUAL DEVICE EVALUATION HAS BEEN COMPLETED AND THE RESULTS ARE AS FOLLOWS: CORRECTED: A1 DHR RESULTS THE DHR WAS REVIEWED FOR CASE#1119961140 AND THERE WAS NO EVIDENCE DISCOVERED TO INDICATE THAT A PRODUCT DEFECT OR NON-CONFORMITY CONTRIBUTED TO THE ISSUE. SUPPLIER (GARRECO) REVIEWED THE ASSOCIATED MATERIAL LOT AND CONFIRMED NO MANUFACTURING DEVIATION OR ABNORMALITY. (SEE ATTACHMENT) ACRYLIC: LOT# 940122 WAS MANUFACTURED FROM JANUARY 2022 AND WAS ASSIGNED AN EXPIRATION OF JANUARY 2027. SUPPLIER (MYERSON) REVIEWED THE ASSOCIATED MATERIAL LOT AND CONFIRMED NO MANUFACTURING DEVIATION OR ABNORMALITY. (SEE ATTACHMENT) DISK: LOT# TD11736 WAS MANUFACTURED FROM DECEMBER 9, 2022 AND WAS ASSIGNED AN EXPIRATION OF NOVEMBER 29, 2023. BUTTON: LOT# BN2B092322 WAS MANUFACTURED FROM SEPTEMBER 23, 2022 AND WAS ASSIGNED AN EXPIRATION OF SEPTEMBER 23, 2025. BITE PAD: LOT# B053022 WAS MANUFACTURED FROM MAY 30, 2022 AND WAS ASSIGNED AN EXPIRATION OF MAY 30, 2025. STRAP: LOT# SA260937A WAS MANUFACTURED FROM JUNE 16, 2022 AND WAS ASSIGNED AN EXPIRATION OF JUNE 16, 2025. SUPPLIER (KEYSTONE) REVIEWED THE ASSOCIATED MATERIAL LOT AND CONFIRMED NO MANUFACTURING DEVIATION OR ABNORMALITY. (SEE ATTACHMENT) MONOMER: LOT#MC8891 WAS MANUFACTURED FROM FEBRUARY 23, 2022 AND WAS ASSIGNED AN EXPIRATION OF FEBRUARY 23, 2025. STOCK PRODUCT REVIEWED RESULTS NO STOCK PRODUCT WAS AVAILABLE FOR REVIEW SINCE THE DEVICE WAS FABRICATED PER PHYSICIAN'S PRESCRIPTION ONLY. INVESTIGATION METHODS/RESULTS CUSTOMER HAS NOT RETURNED THE PRODUCT OR PROVIDED AN IMAGE FOR REVIEW. HOWEVER, THE NON-VISUAL DEVICE INVESTIGATION HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 0

    THE DEVICE HAS NOT BEEN RETURNED. IF/ WHEN THE DEVICE IS RETURNED AN INVESTIGATION WILL BE CARRIED OUT AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THIS COMPLAINT WILL BE KEPT ON RECORD FOR TRACK AND TRENDING PURPOSES. SECTION A2: THE PATIENTS DATE OF BIRTH WAS NOT PROVIDED WHEN ASKED. SECTION A4: THE PATIENTS WEIGHT IS NOT PROVIDED WHEN ASKED. SECTION A5/A6: THIS INFORMATION NOT PROVIDED WHEN ASKED. SECTION B3: THIS INFORMATION WAS NOT PROVIDED WHEN ASKED. SECTION D4: IS NOT APPLICABLE WITH THE EXCEPTION OF SERIAL NUMBER AS THE DEVICE IS MANUFACTURED BY PRESCRIPTION. SECTION D6-D7: IS NOT APPLICABLE AS THE DEVICE IS MANUFACTURED BY PRESCRIPTION AND NOT IMPLANTABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD A REACTION TO THE EMA THAT WAS ISSUED. IT IS UNCLEAR WHEN THE PATIENT RECEIVED THE DEVICE. THE PATIENT REPORTED THAT THEIR LIPS HAD SWOLLEN AROUND THE BUCCAL MUCOUS. PRIOR TO THIS INCIDENT, IT WAS NOTED THAT THE PATIENT'S TONGUE AND THROAT SWELLED UP. THE SYMPTOMS WENT AWAY AT THE END OF THE DAY OR A DAY AND A HALF AFTER TAKING BENADRYL. THE PATIENT DISCONTINUED USE OF THE DEVICE. THE PATIENT HAS NO KNOWN ALLERGIES BUT WILL GET AN ALLERGY TEST FROM THEIR MEDICAL PROVIDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1262438 EMA HALF UPPER ANTI SNORING NIGHTGUARD LRK PRISMATIK DENTALCRAFT, INC. 1119961140

    Patients

    Seq Age Sex Outcome Treatment
    1 Female