BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SALTER LABS

    MDR report key: 17848805 · Received September 29, 2023

    Report

    Report Number
    3000219639-2023-00027
    Event Type
    Injury
    Date Received
    September 29, 2023
    Date of Event
    August 30, 2023
    Report Date
    September 29, 2023
    Manufacturer
    SALTER LABS
    Product Code
    BZD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    117

    Narratives

    Additional Manufacturer Narrative · 0

    THE INCORRECT SIZES AND VARYING SHADES OF PRODUCT COULD BE THE CAUSE OF THE SKIN BREAKDOWN. THE CANNULAIDE WAS DOCUMENTED TO CAUSE SKIN DAMAGE IN NEONATAL PATIENTS UNKNOWN IF IT WAS THE CAUSE OF THE INCORRECT SIZE OR SHADE OF THE PRODUCT.

    Additional Manufacturer Narrative · 0

    THE INCORRECT SIZES AND VARYING SHADES OF PRODUCT COULD BE THE CAUSE OF THE SKIN BREAKDOWN. THE CANNULAIDE WAS DOCUMENTED TO CAUSE SKIN DAMAGE IN NEONATAL PATIENTS UNKNOWN IF IT WAS THE CAUSE OF THE INCORRECT SIZE OR SHADE OF THE PRODUCT. COMPLAINT HISTORY REVIEWED. THERE HAVE BEEN NO SIMILAR COMPLAINTS IN THE PREVIOUS 24 MONTHS FOR CA10X PRODUCTS. BACKGROUND INFORMATION REVIEWED. NO LOT# PROVIDED. CUSTOMER HAS PURCHASED PRODUCT SEVERAL TIMES OVER THE LAST 6 MONTHS. "BAD" PRODUCT SHOWN IN PICTURE APPEARS TO BE OLDER PRODUCT, HOWEVER WITHOUT RETURNED MATERIAL OR LOT# FURTHER ASSESSMENT CANNOT BE CONDUCTED. RISK(RMA-20011): R27: PATIENT'S SKIN IS SENSITIVE TO DEVICE REMOVAL - AGE, MEDICATION, EXISTING SKIN DAMAGE, INDIVIDUAL PATIENT SENSITIVITY - S=7 O=4 RPN=28. SEE RMA-20011 NOTE 6 FOR JUSTIFICATION FOR RPN > 25.

    Description of Event or Problem · 0

    THEY HAVE BEEN SUPPLIED CANNNULAIDE IN INCORRECT SIZES AND WITH VARYING SHADES OF PRODUCT AND SKIN BREAKDOWN. THE NEW CANNULAS ARE CAUSING SKIN BREAKDOWN FOR OUR BABIES.

    Description of Event or Problem · 0

    THEY HAVE BEEN SUPPLIED CANNNULAIDE IN INCORRECT SIZES AND WITH VARYING SHADES OF PRODUCT AND SKIN BREAKDOWN. THE NEW CANNULAS ARE CAUSING SKIN BREAKDOWN FOR OUR BABIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1975902 SALTER LABS CANNULAIDE SIZE 3, BABIES 2000G-3000G, SIZE 2, 1250G-2000G, SIZE 1, 700G-1250 BZD SALTER LABS CA101-0-25,CA102-0-25,CA103-0-25

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other