BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GOODSENSE

    MDR report key: 8345618 · Received February 15, 2019

    Report

    Report Number
    1038758-2019-00006
    Event Type
    Injury
    Date Received
    February 15, 2019
    Date of Event
    January 10, 2019
    Report Date
    January 17, 2019
    Manufacturer
    JIANGSU NANFANG MEDICAL CO. LTD.
    Product Code
    KGX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    AS OF 02/12/2019, RETURNED PRODUCT WAS SUBMITTED TO THE LAB FOR TESTING. ASO NOTIFIED THE MANUFACTURER ABOUT THE EVENT. I ADDNITON, SATISFACTORY BIOCOMPATIBILITY TEST RESULTS FOR THE MATERIALS USED TO MANUFACTURE THE SAME TYPE OF PRODUCTS WERE REVIEWED. REFER TO RELEVANT TESTS/LABORATORY DATA FOR FURTHER DETAILS. TAPE IS A COMMONLY WELL KNOWN PRODUCT WHERE COMMON USES ARE KNOWN TO ORDINARY INDIVIDUALS. CONSUMER STATED THAT TAPE WAS APPLIED TO SECURE A DRESSING, THEREFORE CORRECT INTENDED USE. COMPLAINT WAS ADDED TO ASO SYSTEM FOR TRACKING AND TRENDING. TO THIS DATE, THERE IS NO EVIDENCE OF A TREND ASSOCIATED WITH THE TAPE THAT WOULD INDICATE AN INCREASED RISK TO USER SAFETY. AS OF 04/22/2019 MANUFACTURER HAS PERFORMED ADDITIONAL TESTING WITH RETAINED SAMPLES FROM OTHER LOT NUMBERS. THE RESULTS ARE ACCEPTABLE WITH NO DEFECTS FOUND DURING TESTING. REFER TO RELEVANT TESTS LABORATORY DATA FOR FURTHER DETAILS.

    Description of Event or Problem · 0

    THE INITIAL REPORT ON 01/17/2019 CONSUMER STATED THAT MULTIPLE LAYERS OF HIS SKIN WERE TORN OFF AND STUCK TO THE PRODUCT AFTER REMOVING THE TAPE. TAPE WAS USED TO KEEP ON A GAUZE FOR A CUT INCURRED ON THE BOTTON OF THE CUSTOMER FOOT WHILE ON THE BEACH. CONSUMER REPORTED THAT PRODUCT REMOVAL CAUSED A SEVERE, LARGE AND DEEP AND PAINFUL TEAR OF MULTIPLE LAYERS OF SKIN, RESULTING IN DRAINAGE AND BLEEDING FROM THIS NEW WOUND. THE COMPLETE CUSTOMER INFORMATION REQUEST (CIR) WAS RECEIVED ON 01/30/2019. CONSUMER STATED THAT HE REQUIRED MEDICAL TREATMENT. IT WAS PRESCRIBED TOPICAL BACTROBAN. IT WAS ALSO PRESCRIBED BACTRIM IN CASE SIGNS OF INFECTION OCCURS.

    Additional Manufacturer Narrative · 1

    AS OF 02/12/2019 RETURNED PRODUCT WAS SUBMITTED TO THE LAB FOR TESTING. ASO NOTIFIED THE MANUFACTURER ABOUT THE EVENT. IN ADDITION, SATISFACTORY BIOCOMPATIBILITY TEST RESULTS FOR THE MATERIALS USED TO MANUFACTURE THE SAME TYPE OF PRODUCTS WERE REVIEWED. TAPE IS A COMMONLY WELL KNOWN PRODUCT WHERE COMMON USES ARE KNOWN TO ORDINARY INDIVIDUALS. CONSUMER STATED THAT TAPE WAS APPLIED TO SECURE A DRESSING, THEREFORE CORRECT INTENDED USE. COMPLAINT WAS ADDED TO ASO SYSTEM FOR TRACKING AND TRENDING. TO THIS DATE, THERE IS NO EVIDENCE OF A TREND ASSOCIATED WITH THE TAPE THAT WOULD INDICATE AN INCREASED RISK TO USER SAFETY.

    Description of Event or Problem · 1

    THE INITIAL REPORT ON (B)(6) 2019, CONSUMER STATED THAT MULTIPLE LAYERS OF HIS SKIN WERE TORN OFF AND STUCK TO THE PRODUCT AFTER REMOVING THE TAPE. TAPE WAS USED TO KEEP ON A GAUZE FOR A CUT INCURRED ON THE BOTTOM OF THE CUSTOMER FOOT WHILE ON THE BEACH. CONSUMER REPORTED THAT PRODUCT REMOVAL CAUSED A SEVERE, LARGE AND DEEP AND PAINFUL TEAR OF MULTIPLE LAYERS OF SKIN, RESULTING IN DRAINAGE AND BLEEDING FROM THIS NEW WOUND. THE COMPLETE CUSTOMER INFORMATION REQUEST (CIR) WAS RECEIVED ON (B)(6) 2019. CONSUMER STATED THAT HE REQUIRED MEDICAL TREATMENT. IT WAS PRESCRIBED TOPICAL BACTROBAN. IT WAS ALSO PRESCRIBED BACTRIM IN CASE SIGNS OF INFECTION OCCURS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    139238 GOODSENSE WATERPROOF ADHESIVE TAPE KGX JIANGSU NANFANG MEDICAL CO. LTD. UPC#180410000774

    Patients

    Seq Age Sex Outcome Treatment
    1 Other