BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIP 24 SURGICAL SKIN CLOSURE DEVICE

    MDR report key: 8529979 · Received April 18, 2019

    Report

    Report Number
    3009673389-2019-00005
    Event Type
    Injury
    Date Received
    April 18, 2019
    Date of Event
    March 15, 2019
    Report Date
    March 19, 2019
    Manufacturer
    ZIPLINE MEDICAL
    Product Code
    KGX
    PMA / PMN Number
    510K EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    SEE USER FACILITY VOLUNTARY EMDR REPORT NUMBER MW5085077 (ATTACHED). SUBCUTANEOUS INCISION CLOSURE WAS PERFORMED USING RUNNING BARBED SUTURES. SURFACE CLOSURE WAS COMPLETED USING SURGICAL STAPLES AND THE ZIPSEAL 24 SKIN CLOSURE CONVENIENCE KIT, WHICH CONSISTS OF THE ZIP 24 SURGICAL SKIN CLOSURE DEVICE (SUSPECT MEDICAL DEVICE) AND THE CARDINAL HEALTH TOPICAL SKIN ADHESIVE (CONCOMITANT MEDICAL PRODUCT). INVESTIGATION DETERMINED THAT EVENT WAS CAUSED BY INADEQUATE DEEP SUTURING. DATA CORRECTIONS: B5 - REMOVED "NO FURTHER DETAILS WERE REPORTED." ADDED "FACILITY REPORTED THAT PATIENT COMPLAINED OF BLEEDING. A PRE-INTERVENTION DIAGNOSIS OF "WOUND DEHISCENCE RIGHT TOTAL HIP ARTHROPLASTY WITH DRAINAGE." WAS REPORTED BY MEDICAL STAFF DURING FOLLOW-UP INVESTIGATION." H6 - UPDATED EVENT PROBLEM AND EVALUATION CODES H10 - REMOVED "DETERMINATION OF ROOT CAUSE WAS NOT POSSIBLE DUE TO LACK OF INFORMATION PROVIDED BY MEDICAL STAFF." ADDED "INVESTIGATION DETERMINED THAT EVENT WAS CAUSED BY INADEQUATE DEEP SUTURING." - ATTACHMENT: [VOLUNTARY USER FACILITY REPORT MW508577.PDF].

    Description of Event or Problem · 0

    TOTAL HIP ARTHROPLASTY PATIENT WAS RE-ADMITTED TO OR FOR RE-CLOSURE OF SURGICAL INCISION AFTER PATIENT DISCHARGE ON POD 4. FACILITY REPORTED THAT PATIENT COMPLAINED OF BLEEDING. A PRE-INTERVENTION DIAGNOSIS OF "WOUND DEHISCENCE RIGHT TOTAL HIP ARTHROPLASTY WITH DRAINAGE." WAS REPORTED BY MEDICAL STAFF DURING FOLLOW-UP INVESTIGATION. SEE VOLUNTARY REPORT NUMBER MW5085077 GENERATED BY USER FACILITY.

    Additional Manufacturer Narrative · 1

    SEE USER FACILITY VOLUNTARY EMDR REPORT NUMBER MW5085077. SUBCUTANEOUS INCISION CLOSURE WAS PERFORMED USING RUNNING BARBED SUTURES. SURFACE CLOSURE WAS COMPLETED USING SURGICAL STAPLES AND THE ZIPSEAL 24 SKIN CLOSURE CONVENIENCE KIT, WHICH CONSISTS OF THE ZIP 24 SURGICAL SKIN CLOSURE DEVICE (SUSPECT MEDICAL DEVICE) AND THE CARDINAL HEALTH TOPICAL SKIN ADHESIVE (CONCOMITANT MEDICAL PRODUCT). DETERMINATION OF ROOT CAUSE WAS NOT POSSIBLE DUE TO LACK OF INFORMATION PROVIDED BY MEDICAL STAFF. [VOLUNTARY USER FACILITY REPORT MW508577.PDF].

    Description of Event or Problem · 1

    TOTAL HIP ARTHROPLASTY PATIENT WAS RE-ADMITTED TO OPERATING ROOM FOR RE-CLOSURE OF SURGICAL INCISION AFTER PATIENT DISCHARGE ON POD 4. NO FURTHER DETAILS WERE PROVIDED. SEE VOLUNTARY REPORT NUMBER MW5085077 GENERATED BY USER FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320164 ZIP 24 SURGICAL SKIN CLOSURE DEVICE TAPE-BASED WOUND CLOSURE KGX ZIPLINE MEDICAL PS1240 0000110434

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention CARDINAL HEALTH TOPICAL SKIN ADHESIVE| SURGICAL STAPLES