BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EMA

    MDR report key: 17257655 · Received July 5, 2023

    Report

    Report Number
    3011649314-2023-00439
    Event Type
    Injury
    Date Received
    July 5, 2023
    Report Date
    December 5, 2023
    Manufacturer
    PRISMATIK DENTALCRAFT, INC.
    Product Code
    LRK
    PMA / PMN Number
    K971794
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HAS BEEN RETURNED. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE SUBMITTED. SECTION A2: THE PATIENTS DATE OF BIRTH WAS NOT PROVIDED WHEN ASKED. SECTION A4: THE PATIENTS WEIGHT IS NOT PROVIDED WHEN ASKED. SECTION A4: THE PATIENTS WEIGHT IS NOT PROVIDED AS IT IS NOT TAKEN AT THE TIME OF THE APPOINTMENT. SECTION A5/A6: THIS INFORMATION NOT PROVIDED WHEN ASKED. SECTION B3: THIS INFORMATION WAS NOT PROVIDED WHEN ASKED. SECTION B6/B7: 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

    Additional Manufacturer Narrative · 0

    THE DEVICE HAS BEEN RETURNED. THE DEVICE EVALUATION HAS BEEN COMPLETED AND THE RESULTS ARE AS FOLLOWS: DHR RESULTS THE DHR WAS REVIEWED AND THERE WAS NO EVIDENCE DISCOVERED TO INDICATE THAT A PRODUCT DEFECT OR NON-CONFORMITY CONTRIBUTED TO THE ISSUE. SUPPLIER ((B)(4)) 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# SA260937B 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 THE PRODUCT WAS RETURNED IN THE ORIGINAL CASE. THE RETURNED DEVICE WAS VISUALLY INSPECTED AND NO DEFECT OR ABNORMALITY WAS OBSERVED. (SEE ATTACHED IMAGES) THERE WAS NO EVIDENCE FOUND TO INDICATE THAT THE REPORTED ISSUE WAS CAUSED BY THE DEVICE ITSELF. ROUGHNESS - THE FLANGE WAS SMOOTH; INTERNAL/EXTERNAL SURFACES WERE SMOOTH. CRACK - NO MAJOR CRACK WAS FOUND. DELAMINATION - LAYERS WERE INTACT AND DID NOT SEPARATE. DISCOLORATION - THE DEVICE WAS CLEAR AND TRANSPARENT. GENERAL CLEANLINESS - THE RETURNED DEVICE APPEARED TO BE CLEAN, FREE OF DEBRIS OR FOREIGN PARTICLES.

    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, WHEN THE PATIENT FIRST USED THE DEVICE, OR WHEN THE REACTION OCCURRED OR RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1887538 EMA ANTI SNORING NIGHTGUARD LRK PRISMATIK DENTALCRAFT, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Female