BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CVS/PHARMACY

    MDR report key: 7325341 · Received March 8, 2018

    Report

    Report Number
    1038758-2018-00007
    Event Type
    Injury
    Date Received
    March 8, 2018
    Date of Event
    February 8, 2018
    Report Date
    February 9, 2018
    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

    AS OF (B)(6) 2018 ASO DID NOT RECEIVE INFORMATION FROM THE CONSUMER OF THE LOT NUMBER AND HAS NOTIFIED THE MANUFACTURER. SATISFACTORY BIOCOMPATIBILITY TEST RESULTS FOR THE MATERIALS USED TO MANUFACTURE THE SAME TYPE OF PRODUCTS WERE REVIEWED. IT APPEARS THAT THE USER USED THE TAPE INCORRECTLY BY USING THE TAPE DIRECTLY ON THE WOUND.

    Additional Manufacturer Narrative · 1

    AS OF 03/07/2018 ASO DID NOT RECEIVE INFORMATION FROM THE CONSUMER OF THE LOT NUMBER AND HAS NOTIFIED THE MANUFACTURER. SATISFACTORY BIOCOMPATIBILITY TEST RESULTS FOR THE MATERIALS USED TO MANUFACTURE THE SAME TYPE OF PRODUCTS WERE REVIEWED. IT APPEARS THAT THE USER USED THE TAPE INCORRECTLY BY USING THE TAPE DIRECTLY ON THE WOUND. AS OF 03/30/2018 CONSUMER RECEIVED COMPLETED CIR AND UNUSED PRODUCT. HOWEVER, LOT NUMBER COULD NOT BE IDENTIFIED. CONSUMER STATED THAT TAPE WAS APPLIED TO SECURE DRESSING, THEREFORE CORRECT INTENDED USE. UNUSED RETURNED PRODUCT WAS SUBMITTED TO THE LAB FOR TESTING. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT HER HUSBAND USED THE PRODUCT OVER TWO WOUNDS. THE PRODUCT CAUSED RED BUMPS FILLED WITH WATER.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT HER HUSBAND USED THE PRODUCT OVER TWO WOUNDS. THE PRODUCT CAUSED RED BUMPS FILLED WITH WATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    167790 CVS/PHARMACY EASY TEAR ADHESIVE TAPE KGX JIANGSU NANFANG MEDICAL CO. LTD. UPC#050428269084

    Patients

    Seq Age Sex Outcome Treatment
    1