BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EMA

    MDR report key: 18079122 · Received November 6, 2023

    Report

    Report Number
    3004588608-2023-00002
    Event Type
    Injury
    Date Received
    November 6, 2023
    Date of Event
    September 25, 2021
    Report Date
    October 9, 2023
    Manufacturer
    THE MYERSON COMPANY LIMITED
    Product Code
    LRK
    PMA / PMN Number
    K971794
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING INFORMATION WAS NOT PROVIDED BY THE CUSTOMER: A2:- PATIENT DATE OF BIRTH. A5:- PATIENT ETHNICITY. A6:- PATIENT RACE. B2:- THIS HARM WAS NOT CONSIDERED TO BE AN ADVERSE EVENT SINCE THE INCIDENT DID NOT RESULT IN DEATH OR SERIOUS INJURY AND DOES NOT HAVE THE LIKELIHOOD TO RESULT IN DEATH OR SERIOUS INJURY TO THE PATIENT. THIS IS BEING REPORTED OUT OF AN ABUNDANCE OF CAUTION AND AS PER GUIDANCE BY AN FDA INSPECTOR WHO ADVISED THAT THE FDA MIGHT BE INTERESTED IN THE DATA FOR TRENDING PURPOSES. D4:- THE DEVICE COMPRISES OF 4 SETS OF COMPONENTS. THE LOT # FOR THE 4TH ITEM, THE STRAPS, IS # S041021. THE EXPIRY DATES ARE AS FOLLOWS: EMATD12010 =2023-12-28. EMABN2 =2023-11-28. EMABP = 2023-12-05. EMAST21YM =2024-04-10.

    Description of Event or Problem · 0

    THE DISTRIBUTOR RECEIVED AN EMAIL FROM THE THERMOFORM GROUP ON 7-6-22. IT WAS REPORTED THAT THE PATIENT HAD A REACTION TO THE EMA DEVICE THAT WAS ISSUED. THE DEVICE WAS ISSUED ON (B)(6) 2021 (AFTER REPAIR) AND WAS FIRST USED ON THAT DAY. THE REACTION OCCURRED ON (B)(6) 2021. THE PATIENT EXPERIENCED "TINGLING/NUMBNESS ON THE TISSUE SURROUNDING THE LIP AND TONGUE. THERE WAS NO TREATMENT REQUIRED, BUT THE PATIENT WAS ADVISED TO DISCONTINUE THE DEVICE ON (B)(6) 2022 AND HAD IMPROVED. THERE ARE NO ALLERGIES NOTED. NO ALLERGY TEST HAS BEEN IDENTIFIED, HOWEVER THE PATIENT WAS ADVISED TO SEEK AN ALLERGIST FOR DEFINITIVE RESULT. WITH REGARDS TO THE DEVICE: THE DEVICE WAS RINSED WITH WATER AN PERIDEX PRIOR TO DELIVERY. NO INFORMATION WAS PROVIDED WITH REGARDS TO HOW THE PATIENT CLEANED AND STORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1284138 EMA SLEEP DEVICE LRK THE MYERSON COMPANY LIMITED EMATD12010,EMABN2,EMABP,EMAST21YM TD122820, BN2B112820 ,BPB12052

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Male