BEUDAMED
    FDA Adverse Event Injury Summary report: N

    C6S 2.5,BTH

    MDR report key: 15089466 · Received July 22, 2022

    Report

    Report Number
    2133409-2022-00003
    Event Type
    Injury
    Date Received
    July 22, 2022
    Date of Event
    April 8, 2021
    Report Date
    July 22, 2022
    Manufacturer
    BRAEMAR MANUFACTURING, LLC
    Product Code
    DSI
    UDI-DI
    B146BTPM0
    PMA / PMN Number
    K153473
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BRAEMAR MANUFACTURING, LLC RECEIVED AN ALLEGATION OF BURNS TO A PATIENT'S CHEST AREA. BRAEMAR ATTEMPTED TO REQUEST A DEVICE RETURN FROM THE CUSTOMER, BUT THE CUSTOMER NOTIFIED THAT THE DEVICE WAS DEEMED "LOST/STOLEN" AND COULD NOT BE RETRIEVED OR RETURNED. THE COMPLAINANT WAS NOT ABLE TO PROVIDE ADDITIONAL INFORMATION ON THE ALLEGATION OF BURNS ASSOCIATED WITH THE COMPLAINT. THE QUALITATIVE DESCRIPTION OF "BURNS" COULD NOT BE SUBSTANTIATED WITH FURTHER DESCRIPTION AND/OR PICTURES TO ASSESS THE CLAIM. AS A RESULT, A SKIN IRRITATION CATEGORIZATION COULD NOT BE PERFORMED. WHILE THE COMPLAINANT INDICATED A CLAIM OF MEDICAL CONSULT, THERE IS NO EVIDENCE OR ALLEGATION THAT MEDICAL OR PRESCRIPTIVE TREATMENT WAS NECESSITATED. SENSOR DOES NOT MAKE CONTINUOUS CONTACT WITH PATIENTS SKIN. A REVIEW OF THE ELECTRODES SENT WITH THE MCOT PACKAGE SHOWS THAT THE VERMED ELECTRODES WERE SENT TO THE PATIENT AND HAVE AN ADHESIVE WHICH MAKES CONTACT WITH THE SKIN AND IS LIKELY TO BE THE CAUSE OF THE ALLEGED EVENT.

    Description of Event or Problem · 0

    WHEN PATIENT REMOVED DEVICE FOR THE FIRST TIME AS INSTRUCTED, IT IS ALLEGED THAT SHE SUSTAINED INJURIES (BLEEDING AND BURN MARKS).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    571199 C6S 2.5,BTH C6 MCOT DSI BRAEMAR MANUFACTURING, LLC C6S 2.5,BTH B146BTPM0

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other