BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CVS

    MDR report key: 14364044 · Received May 11, 2022

    Report

    Report Number
    1038758-2022-00014
    Event Type
    Injury
    Date Received
    May 11, 2022
    Date of Event
    April 12, 2022
    Report Date
    May 10, 2022
    Manufacturer
    YANGZHOU SUPER-UNION MEDICAL MATERIAL CO., LTD.
    Product Code
    NAB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE INITIAL COMPLAINT BY THE CUSTOMER DID NOT INDICATE THAT AN MDR WOULD BE REQUIRED. HOWEVER, PER THE INFO RECEIVED ON (B)(6) 2022 MEDICAL TREATMENT WAS SOUGHT. BASED ON THE INFORMATION RECEIVED, ASO OPTED TO FILE AN MDR. ASO COULD NOT NOTIFY MANUFACTURED OF THE PRODUCT AS THIS PARTICULAR PRODUCT LOT WAS MANUFACTURED IN 2010, AND IS PASS THE 7 YEARS RECORD RETENTION POLICY, SO NO MANUFACTURER RECORDS OR RETAINED SAMPLES ARE AVAILABLE PHYSICALLY FROM THE MANUFACTURER FOR EVALUATION. ALSO ASO DOES NOT CONDUCT BUSINESS CURRENTLY WITH THE AFOREMENTIONED MANUFACTURER. AS OF 05/06/2022 UNUSED RETURNED PRODUCT AND PRESHIPMENT DOCUMENTATION WERE REVIEWED BY ASO QA LAB, WITH NO ISSUES OR DEVIATIONS NOTED. IN ADDITION, ASO HAS REVIEWED RECORDS OF BIOCOMPATIBILITY TESTS AND LATEX SCREENING. REFER TO SECTION OF THIS REPORT FOR FURTHER DETAILS.

    Description of Event or Problem · 0

    ON THE INITIAL REPORT RECEIVED BY ASO ON (B)(6) 2022 CONSUMER REPORTED THAT SHE USED THE PRODUCT TO COVER WHERE SHE HAD SURGERY. CONSUMER STATES THAT SHE GOT AN ITCHY, PAINFUL REACTION IN THE EXACT OUTLINE OF THE PAD. ON COMPLETED CIR RECEIVED FROM CONSUMER ON (B)(6) 2022 SHE STATED THAT THE INCISION WAS FINE BUT SHE HAD SWOLLEN, IRRITATED, BLISTERED SKIN IN THE AREA WHERE SHE HAD APPLIED THE PAD. SHE ADDED THAT SHE RETURNED TO THE SURGEON WHO ADVISED HER TO USE HYDROCORTISONE CREAM. SHE ADDED THAT THE REDNESS HAS MOSTLY DISAPPEARED BUT SOME REMAINS AND IS STILL ITCHY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    569060 CVS GAUZE PADS NAB YANGZHOU SUPER-UNION MEDICAL MATERIAL CO., LTD. UPC#050428606063 2384-20100714

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other