BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFEWATCH MOBILE CARDIAC TELEMETRY 1 LEAD PATCH

    MDR report key: 8739030 · Received June 27, 2019

    Report

    Report Number
    2133409-2019-00007
    Event Type
    Injury
    Date Received
    June 27, 2019
    Date of Event
    May 23, 2019
    Report Date
    February 27, 2020
    Manufacturer
    BRAEMAR MANUFACTURING, LLC
    Product Code
    DSI
    UDI-DI
    00850725007040
    PMA / PMN Number
    K151269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PER PATIENT USER GUIDE SUP559, PATIENTS ARE INSTRUCTED TO NOT USE THE PATCH IF THEY HAVE KNOWN ALLERGIES TO NICKEL OR OTHER METALS, AND TO INFORM THEIR PHYSICIAN IF THEY HAVE KNOWN SENSITIVITY TO MEDICAL ADHESIVES. THE PATIENT IS ALSO INFORMED IN THE USER GUIDE THAT REDDENING CAN OCCUR DURING THE NORMAL USE OF PATCH, AND THAT IF THEY DEVELOP SKIN IRRITATION THEY SHOULD REMOVE THE PATCH AND SEEK MEDICAL ATTENTION. THE SKIN IRRITATION REPORTED BY THE PATIENT WAS EXPERIENCING, "ITCHY, PULLED SKIN OFF, VERY RED, RIPPED OFF THE ENTIRE LEFT SIDE, BLEEDING, BLISTERS", AND TO ENSURE PATIENT COMFORT, THE PATIENT WAS OFFERED MCT 3 LEAD DEVICE THAT PROVIDES ELECTRODES FOR PATIENTS WITH SKIN SENSITIVES OR ALLERGIES. NO ADDITIONAL INFORMATION IS AVAILABLE AT PRESENT REGARDING THE CASE. ATTEMPTS TO FURTHER CONTACT THE PATIENT WERE UNSUCCESSFUL. NO ADDITIONAL QUALITATIVE DATA (E.G., PICTURES) IS AVAILABLE FOR CASE REVIEW, TO ADDRESS THE CLAIMS IDENTIFIED. PER CLINICAL AFFAIRS REVIEW BY QUALIFIED PERSON ((B)(6) , RN, MSN, CDE), PAIN IS A SUBJECTIVE SYMPTOM AND MAY VARY FROM PERSON TO PERSON. THE CASE WAS REPORTED TO US FDA AS 2019_00007 DUE TO THE PATIENT'S CLAIM OF PASSING OUT FROM PAIN. A ROOT CAUSE ANALYSIS POSITION PAPER FOR SKIN IRRITATION IS AVAILABLE AND HAS BEEN IDENTIFIED IN THE CASE FILE (03-06816 REV. A). THE PATIENT SELF-TREATED WITH ALCOHOL, WHICH MAY EXACERBATE SKIN IRRITATION BY FURTHER DRYING AND IRRITATING THE SKIN. NO CONSERVATIVE CARE ACTIONS WERE NOTED IN THE COMPLAINT CASE. THE PATIENT WAS SWITCHED TO AN ALTERNATE DEVICE AND WAS ABLE TO CONTINUE MONITORING WITH ALTERNATE ELECTRODES FOR PERSONS WITH SKIN SENSITIVITIES OR ALLERGIES. ALTHOUGH THE PATIENT DID NOT FINISH THE MONITORING PERIOD, IT IS REASONABLY CONCLUDED BY CLINICAL AFFAIRS (QUALIFIED PERSON, MS. (B)(6) ) THAT THE PATIENT'S CONDITION DID NOT WORSEN. THE PATIENT DID NOT SEEK OR NECESSITATE MEDICAL TREATMENT TO ADDRESS THE SKIN IRRITATION AND WAS ABLE TO SWITCH TO THE ALTERNATE SYSTEM. NO CAPA ACTIONS WILL BE TAKEN TO ADDRESS THE EVENT, AS NO DEVICE DEFICIENCY COULD BE CONFIRMED OR REPLICATED. PATIENT USE CASE FACTORS WERE IDENTIFIED. CASE WILL BE TRACKED AND TRENDED. PER 03-06816 REV. A, THE CASE IS CATEGORIZED AS "MILD TO MODERATE INJURY AFFECTING THE EPIDERMIS AND DERMIS, RESPONSIVE TO CONSERVATIVE CARE WITHIN 7 DAYS". NO ADDITIONAL INFORMATION IS KNOWN TO (B)(4), INC. AND BRAEMAR MANUFACTURING, LLC AT THIS TIME.

    Description of Event or Problem · 0

    ON (B)(6) 2019, PATIENT NOTIFIED (B)(4), INC. OF SKIN IRRITATION/BLISTERS, INCLUDING ALLEGATION THAT PATIENT PASSED OUT FROM PAIN ASSOCIATED WITH EVENT. NOTE: BECOME AWARE DATE IS (B)(6) 2019, PER COMPLAINT CASE GENERATED ((B)(4)).

    Additional Manufacturer Narrative · 1

    PER PATIENT USER GUIDE SUP559, PATIENTS ARE INSTRUCTED TO NOT USE THE PATCH IF THEY HAVE KNOWN ALLERGIES TO NICKEL OR OTHER METALS, AND TO INFORM THEIR PHYSICIAN IF THEY HAVE KNOWN SENSITIVITY TO MEDICAL ADHESIVES. THE PATIENT IS ALSO INFORMED IN THE USER GUIDE THAT REDDENING CAN OCCUR DURING THE NORMAL USE OF PATCH, AND THAT IF THEY DEVELOP SKIN IRRITATION THEY SHOULD REMOVE THE PATCH AND SEEK MEDICAL ATTENTION. THE SKIN IRRITATION REPORTED BY THE PATIENT WAS EXPERIENCING, "ITCHY, PULLED SKIN OFF, VERY RED, RIPPED OFF THE ENTIRE LEFT SIDE, BLEEDING, BLISTERS", AND TO ENSURE PATIENT COMFORT, THE PATIENT WAS OFFERED MCT 3 LEAD DEVICE THAT PROVIDES ELECTRODES FOR PATIENTS WITH SKIN SENSITIVES OR ALLERGIES. THE PATIENT STATED THAT THE DEVICE IS ALREADY REMOVED AND MAILED BACK (NOT RECEIVED BACK FOR EVALUATION). NO ADDITIONAL INFORMATION IS KNOWN TO BRAEMAR MANUFACTURING, LLC AT THIS TIME.

    Description of Event or Problem · 1

    ON (B)(6) 2019, PATIENT NOTIFIED LIFEWATCH SERVICES, INC. OF SKIN IRRITATION/BLISTERS, INCLUDING ALLEGATION THAT PATIENT PASSED OUT FROM PAIN ASSOCIATED WITH EVENT. NOTE: BECOME AWARE DATE IS 05/28/2019, PER COMPLAINT CASE GENERATED (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    533994 LIFEWATCH MOBILE CARDIAC TELEMETRY 1 LEAD PATCH LIFEWATCH MOBILE CARDIAC TELEMETRY 1 LEAD PATCH DSI BRAEMAR MANUFACTURING, LLC MCT 1L 00850725007040

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Other