BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CVS HEALRH

    MDR report key: 9194608 · Received October 15, 2019

    Report

    Report Number
    1038758-2019-00048
    Event Type
    Injury
    Date Received
    October 15, 2019
    Report Date
    August 22, 2019
    Manufacturer
    JIANGSU NANFANG MEDICAL CO. LTD.
    Product Code
    KGX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INITIAL COMPLAINT BY THE CUSTOMER DID NOT INDICATE THAT AN MDR WOULD BE REQUIRED. HOWEVER, PER THE INFO RECEIVED ON (B)(6) 2019 MEDICAL TREATMENT WAS SOUGHT. BASED ON THE INFORMATION RECEIVED, ASO OPTED TO FILE AN MDR. AS OF (B)(6) 2019 UNUSED RETURNED PRODUCT SAMPLES WERE SUBMITTED TO THE LAB FOR TESTING WITH NO DEFECTS NOTED. ASO NOTIFIED THE MANUFACTURER ABOUT THE EVENT. MANUFACTURER EVALUATED RETAINED PRODUCT OF THE SAME LOT WITH NO DEFECTS NOTED. IN ADDITION, ASO REVIEWED RECORDS OF BIOCOMPATIBILITY TESTS. REFER TO SECTION OF THIS REPORT FOR FURTHER DETAILS.

    Description of Event or Problem · 1

    ON THE INITIAL REPORT ON (B)(6) 2019 CONSUMER REPORTED THE PRODUCT TORE SKIN OFF THE BOTTOM OF HIS FOOT UPON REMOVAL. ON (B)(6) 2019 WE RECEIVED COMPLETED CIR FROM CONSUMER THAT STATED HE SOUGHT MEDICAL ATTENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    986069 CVS HEALRH WATERPROOF ADHESIVE TAPE KGX JIANGSU NANFANG MEDICAL CO. LTD. UPC#050428363409 2423-18340

    Patients

    Seq Age Sex Outcome Treatment
    1 Other