BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CVS HEALTH

    MDR report key: 6913617 · Received October 4, 2017

    Report

    Report Number
    1038758-2017-00032
    Event Type
    Injury
    Date Received
    October 4, 2017
    Date of Event
    September 4, 2017
    Report Date
    September 5, 2017
    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 · 1

    AS OF 10/02/2017 ASO DID NOT RECEIVE INFORMATION FROM THE CONSUMER ON THIS LOT NUMBER AND HAS NOTIFIED THE MANUFACTURER. SATISFACTORY BIOCOMPATIBILITY TEST RESULTS FOR THE MATERIALS USED TO MANUFACTURE THE SAME TYPE OF PRODUCTS WERE REVIEWED.

    Additional Manufacturer Narrative · 1

    AS OF 10/02/2017 ASO DID NOT RECEIVE INFORMATION FROM THE CONSUMER ON THIS LOT NUMBER AND HAS NOTIFIED THE MANUFACTURER. SATISFACTORY BIOCOMPATIBILITY TEST RESULTS FOR THE MATERIALS USED TO MANUFACTURE THE SAME TYPE OF PRODUCTS WERE REVIEWED. AS OF 12/18/2017 ASO RECEIVED COMPLETED CIR FROM THE CONSUMER WITH CONFIRMATION OF THE LOT NUMBER. ASO REVIEWED RECORDS FOR ABSORBENCY ON PRE-SHIPMENT SAMPLES AND PERFORMED ABSORPTION CAPACITY ON UNUSED RETURNED PRODUCT. REFER FOR FURTHER DETAILS. THE FOLLOWING SECTIONS WERE UPDATED: CORRECTION ON THE UPC NUMBER AND LOT NUMBER ADDED. CORRECTION - PRODUCT IS NOT LABELED FOR SINGLE USE. (B)(4).

    Description of Event or Problem · 1

    CONSUMER STATED THAT HE NOTICED THAT ONE OF THE ITEMS HAD A GRAYISH-BLACK SPOT ON IT. HE USED AN ITEM WITHOUT THE SPOT AND HE STATED THAT HIS WOUND HAS GOTTEN WORSE.

    Description of Event or Problem · 1

    CONSUMER STATED THAT HE NOTICED THAT ONE OF THE ITEMS HAD A GRAYISH-BLACK SPOT ON IT. HE USED AN ITEM WITHOUT THE SPOT AND HE STATED THAT HIS WOUND HAS GOTTEN WORSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    693784 CVS HEALTH STERILE PADS 4X4 IN NAB YANGZHOU SUPER UNION MEDICAL MATERIAL CO., LTD. UPC#050428367988 2384-20161215

    Patients

    Seq Age Sex Outcome Treatment
    1