BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARDEA SOLO

    MDR report key: 18332737 · Received December 14, 2023

    Report

    Report Number
    3010342616-2023-00001
    Event Type
    Injury
    Date Received
    December 14, 2023
    Date of Event
    July 10, 2023
    Report Date
    July 24, 2024
    Manufacturer
    CARDIAC INSIGHT, INC.
    Product Code
    DSH
    UDI-DI
    00857553006115
    PMA / PMN Number
    K162503
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTERVIEWING/COMMUNICATING WITH THE HEALTHCARE PROFESSIONAL ON HOW THE M300 (SENSOR) WAS APPLIED AND THEIR KNOWLEDGE AND THE PATIENT'S CONDITION AND PROGRESS WAS PART OF THE INVESTIGATION. ADDIITONALLY MANUFACTURING RECORDS AND MATERIALS WERE REVIEWED AND NO DISCREPANCIES WERE IDENTIFIED. FOLLOW-UP WITH THE CLINIC (CYPRESS HEART & VASCULAR CARE, CYPRESS, TX) INDICATED THAT THE PATIENT DID WELL WITH TOPICAL STEROID CREAM.

    Additional Manufacturer Narrative · 0

    D4 HAS UDI RELATED DATA QUALITY UPDATES. UPON REVIEW, THE FOLLOWING CORRECTIONS WERE MADE TO D9 (DEVICE RETURNED), H3 (DEVICE EVALUATED), AND H6 (INVESTIGATION FINDING). B4 (DATE OF THIS REPORT), G6 (TYPE OF REPORT) AND H2 (IF FOLLOW-UP, WHAT TYPE) WERE UPDATED ACCORDINGLY.

    Description of Event or Problem · 0

    PATIENT EXPERIENCED SEVERE RASH AND BLISTERING OF HER SKIN DURING WEAR OF THE M300 (SENSOR). THE PATIENT STARTED EXPERIENCING SOME ITCHING, BURNING AND DISCOMFORT AFTER WEARING THE PATCH FOR 1-2 DAYS. DUE TO DISCOMFORT, THE PATIENT REMOVED THE SENSOR AFTER WEARING IT FOR 4 DAYS AND 21 HOURS (B)(6) 2023). STAFF SAID SHE CAME TO THE CLINIC HOLDING A WET COMPRESS ON THE WOUND AND REQUESTED TO SPEAK WITH THE MEDICAL STAFF. SHE DESCRIBED THAT SHE HAD SOME DISCOMFORT AND REMOVED THE SENSOR EARLY DUE TO CONCERNS, WHEN SHE REMOVED THE PATCH THAT'S WHEN HER SKIN SHOWED THE BLISTERING AND THE RASH. PHYSICIAN INITIALLY SUGGESTED AT-HOME REMEDIES AND CARE. HOWEVER, AFTER A WEEK, THE AREA WASN'T HEALLING SO HE PROVIDED THE PATIENT WITH A TOPICAL STEROID CREAM AND IS MONITORING HER HEALING PROCESS. IT WAS REPORTED (B)(6) 2023 THE PATIENT DID WELL WITH THE TOPICAL STEROID CREAM. ALTHOUGH TEMPERATURES WERE ABOVE NORMAL DURING THE WEAR PERIOD, PATIENT REPORTED TO HAVE SPENT MOST OF THE WEAR PERIOD TIME INDOORS AND WAS NOT WORKING IN THE SUN OR DOING MANY OUTDOOR ACTIVITIES.

    Description of Event or Problem · 0

    PATIENT EXPERIENCED SEVERE RASH AND BLISTERING OF HER SKIN DURING WEAR OF THE M300 (SENSOR). THE PATIENT STARTED EXPERIENCING SOME ITCHING, BURNING AND DISCOMFORT AFTER WEARING THE PATCH FOR 1-2 DAYS. DUE TO DISCOMFORT, THE PATIENT REMOVED THE SENSOR AFTER WEARING IT FOR 4 DAYS AND 21 HOURS ((B)(6) 2023). STAFF SAID SHE CAME TO THE CLINIC HOLDING A WET COMPRESS ON THE WOUND AND REQUESTED TO SPEAK WITH THE MEDICAL STAFF. SHE DESCRIBED THAT SHE HAD SOME DISCOMFORT AND REMOVED THE SENSOR EARLY DUE TO CONCERNS, WHEN SHE REMOVED THE PATCH THAT'S WHEN HER SKIN SHOWED THE BLISTERING AND THE RASH. PHYSICIAN INITIALLY SUGGESTED AT-HOME REMEDIES AND CARE. HOWEVER, AFTER A WEEK, THE AREA WASN'T HEALING SO HE PROVIDED THE PATIENT WITH A TOPICAL STEROID CREAM AND IS MONITORING HER HEALING PROCESS. IT WAS REPORTED (B)(6) 2023 THE PATIENT DID WELL WITH THE TOPICAL STEROID CREAM. ALTHOUGH TEMPERATURES WERE ABOVE NORMAL DURING THE WEAR PERIOD, PATIENT REPORTED TO HAVE SPENT MOST OF THE WEAR PERIOD TIME INDOORS AND WAS NOT WORKING IN THE SUN OR DOING MANY OUTDOOR ACTIVITIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    929084 CARDEA SOLO CARDEA SOLO SENSOR M300 DSH CARDIAC INSIGHT, INC. M300 DC403 00857553006115

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Female Other