BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIP SURGICAL SKIN CLOSURE DEVICE

    MDR report key: 5048485 · Received September 1, 2015

    Report

    Report Number
    3009673389-2015-00006
    Event Type
    Injury
    Date Received
    September 1, 2015
    Date of Event
    July 24, 2015
    Report Date
    August 31, 2015
    Manufacturer
    ZIPLINE MEDICAL INC.
    Product Code
    KGX
    PMA / PMN Number
    CLASSIEXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION - THE LOT NUMBER WAS OBTAINED; THE MANUFACTURING DATE WAS ADDED. CORRECTED INFORMATION - THE MODEL NUMBER AND CATALOG NUMBER WERE CORRECTED FROM PS1160 TO PS1240.

    Description of Event or Problem · 1

    THE PATIENT HAD TKA SURGERY ON (B)(6) 2015. DURING THE PATIENT'S STAY IN THE HOSPITAL, AN ISLAND DRESSING WAS CHANGED AND A NEW ISLAND DRESSING WAS PLACED DIRECTLY OVER THE ZIP DEVICE. THE ISLAND DRESSING ADHESIVE WAS DIRECTLY IN CONTACT WITH THE ZIP DEVICE. THE PATIENT WAS INSTRUCTED TO REMOVE THE ISLAND DRESSING ON (B)(6) 2015 (AT HOME). SINCE THE ISLAND DRESSING ADHESIVE WAS IN DIRECT CONTACT WITH THE ZIP, THE ZIP DEVICE WAS INADVERTENTLY REMOVED ALONG WITH THE ISLAND DRESSING. STERI-STRIPS WERE APPLIED OVER THE INCISION FOR RE-INFORCEMENT.

    Description of Event or Problem · 1

    NO NEW INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    578720 ZIP SURGICAL SKIN CLOSURE DEVICE TAPE BASED WOUND CLOSURE KGX ZIPLINE MEDICAL INC. PS1240 1003718

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention