BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIP SURGICAL SKIN CLOSURE

    MDR report key: 6298885 · Received February 2, 2017

    Report

    Report Number
    3009673389-2017-00001
    Event Type
    Injury
    Date Received
    February 2, 2017
    Date of Event
    January 5, 2017
    Report Date
    January 5, 2017
    Manufacturer
    ZIPLINE MEDICAL
    Product Code
    KGX
    PMA / PMN Number
    510K EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN ASSEMBLY, PACKAGING, AND STERILIZATION PROCESS REVIEW OF THE ZIP DEVICE LOT HISTORY RECORDS WAS PERFORMED. THE REVIEW DID NOT DETECT ANY PROCESS ISSUES THAT COULD CONTRIBUTE TO THE OCCURRENCE OF PATIENT INFECTION OR RESULT IN DEVICE MALFUNCTION THAT COULD CAUSE WOUND DEHISCENCE.

    Description of Event or Problem · 1

    SKIN LAYER OF SURGICAL INCISION SITES FOR IMPLANTED ST. JUDE SPINAL CORD STIMULATOR BATTERY (AT BUTTOCKS) AND ELECTRICAL LEADS (ON SPINE BETWEEN T12-L1) WERE INITIALLY CLOSED ON (B)(6) 2016 WITH MANUFACTURER'S (ZIPLINE MEDICAL, INC.) ZIP 8I SURGICAL SKIN CLOSURE DEVICE. DURING FOLLOW-UP VISIT ON POST-OPERATIVE DAY (POD) 10, THE PHYSICIAN REPORTS THAT WOUND EDGES OF THE BATTERY INCISION WERE NOT FULLY APPROXIMATED (WOUND DEHISCENCE). PHYSICIAN REMOVED THE ZIP 8I CLOSURE DEVICE, CLOSED THE INCISION WITH STERI-STRIPS, AND COVERED THE AREA WITH TEGADERM WOUND DRESSING. NO SIGNS OF INFECTION WERE REPORTED AT THIS TIME BY THE PHYSICIAN. AT POD 50, PATIENT WAS ADMITTED TO (B)(6), WHERE SHE WAS DIAGNOSED WITH CELLULITIS, ABCESS INFECTION, AND WOUND DEHISCENCE. AT CURRENT DATE, KNOWN TREATMENT INCLUDES EXPLANTATION OF SPINAL CORD STIMULATOR SYSTEM. NO OTHER TREATMENT DETAILS NOR PATIENT HEALTH/DISCHARGE STATUS HAVE BEEN MADE AVAILABLE BY THE PHYSICIAN OR HIS STAFF FOLLOWING MULTIPLE REQUESTS FOR INFORMATION. PATIENT RECORDS AND TREATMENT COURSE / PATIENT STATUS DETAILS HAVE BEEN REQUESTED MULTIPLE TIMES FROM THE PHYSICIAN BY ZIPLINE MEDICAL REPRESENTATIVES, BUT HAVE NOT BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78975 ZIP SURGICAL SKIN CLOSURE TAPE BASED WOUND CLOSURE KGX ZIPLINE MEDICAL PS2080 0000037447

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization ST. JUDE SPINAL CORD STIMULATOR IMPLANT| STERI-STRIPS| TEGADERM WOUND DRESSING