BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIP SURGICAL SKIN CLOSURE DEVICE

    MDR report key: 6843408 · Received September 5, 2017

    Report

    Report Number
    3009673389-2017-00005
    Event Type
    Injury
    Date Received
    September 5, 2017
    Date of Event
    August 1, 2017
    Report Date
    August 1, 2017
    Manufacturer
    ZIPLINE MEDICAL
    Product Code
    KGX
    PMA / PMN Number
    510K EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PER 08/01/2017 AND 08/02/2017 EMAILS AND TEXTS RECEIVED FROM THE PHYSICIAN VIA THE ZIPLINE TERRITORY MANAGER, THE THA INCISION WAS CLOSED ON (B)(6) 2017 USING DEEP LAYER BARBED SUTURE, SUBCUTANEOUS BARBED SUTURE, AND SKIN WOUND APPROXIMATION WAS ACHIEVED USING A ZIPLINE MEDICAL ZIP 16 DEVICE. ON (B)(6) 2017 (POD 1), THE PATIENT PRESENTED TO THE CLINIC WITH A SATURATED DRESSING, WHEREUPON THE PHYSICIAN REPLACED THE DRESSING AND SENT THE PATIENT HOME. THE PATIENT THEN RETURNED TO THE CLINIC A SECOND TIME ON (B)(6) 2017 (POD 2) WITH A SATURATED DRESSING. THE PHYSICIAN PERFORMED THE FOLLOWING INTERVENTION STEPS ON (B)(6) 2017: REMOVED THE SATURATED DRESSING. SUTURED THE INCISION CLOSED WITHOUT REMOVING THE ZIP DEVICE. REPLACED THE WOUND DRESSING WITH A NEW DRESSING. MULTIPLE SUBSEQUENT ATTEMPTS TO CONTACT THE PHYSICIAN WERE MADE BY THE ZIPLINE TERRITORY MANAGER ON 08/02/2017, 08/09/2017, AND 08/17/2017 TO OBTAIN FURTHER INFORMATION REGARDING EVENT DETAILS, INTERVENTION METHODS, AND PATIENT OUTCOME WITHOUT SUCCESS. FOLLOW-UP 1: THE ZIPLINE TERRITORY MANAGER ATTEMPTED MULTIPLE TIMES AFTER (B)(6) 2017 TO CONTACT THE PHYSICIAN VIA TEXT MESSAGE, BUT WAS UNABLE TO OBTAIN ANY FURTHER INFORMATION REGARDING THIS CASE. IN PRIOR CASES WHERE BLEEDING OCCURRED, THE EVENT WAS ATTRIBUTED TO FAILURE OF THE DEEP SUTURES; HOWEVER, DUE TO INABILITY TO OBTAIN ANY ADDITIONAL INFORMATION FROM THE PHYSICIAN, NO ROOT CAUSE FOR THE EVENT CAN BE DETERMINED.

    Additional Manufacturer Narrative · 1

    PER (B)(6) 2017 EMAILS AND TEXTS RECEIVED FROM THE PHYSICIAN VIA THE ZIPLINE TERRITORY MANAGER, THE THA INCISION WAS CLOSED ON (B)(6) 2017 USING DEEP LAYER BARBED SUTURE, SUBCUTANEOUS BARBED SUTURE, AND SKIN WOUND APPROXIMATION WAS ACHIEVED USING A ZIPLINE MEDICAL ZIP 16 DEVICE. ON (B)(6) 2017 (POD 1), THE PATIENT PRESENTED TO THE CLINIC WITH A SATURATED DRESSING, WHEREUPON THE PHYSICIAN REPLACED THE DRESSING AND SENT THE PATIENT HOME. THE PATIENT THEN RETURNED TO THE CLINIC A SECOND TIME ON (B)(6) 2017 (POD 2) WITH A SATURATED DRESSING. THE PHYSICIAN PERFORMED THE FOLLOWING INTERVENTION STEPS ON (B)(6) 2017: REMOVED THE SATURATED DRESSING. SUTURED THE INCISION CLOSED WITHOUT REMOVING THE ZIP DEVICE. REPLACED THE WOUND DRESSING WITH A NEW DRESSING. MULTIPLE SUBSEQUENT ATTEMPTS TO CONTACT THE PHYSICIAN WERE MADE BY THE ZIPLINE TERRITORY MANAGER ON 08/02/2017, 08/09/2017, AND 08/17/2017 TO OBTAIN FURTHER INFORMATION REGARDING EVENT DETAILS, INTERVENTION METHODS, AND PATIENT OUTCOME WITHOUT SUCCESS.

    Description of Event or Problem · 1

    PHYSICIAN PROVIDED A PHOTOGRAPH FROM POST-OPERATIVE DAY 1 THAT SHOWS ABNORMAL BLEEDING THROUGH A METHYLENE-BLUE SILVER WOUND DRESSING THAT WAS PLACED OVER A TOTAL HIP ARTHROSCOPY INCISION ON (B)(6) 2017.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    621026 ZIP SURGICAL SKIN CLOSURE DEVICE TAPE BASED WOUND CLOSURE KGX ZIPLINE MEDICAL PS1160 0000051656

    Patients

    Seq Age Sex Outcome Treatment
    1 Other