BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIP SURGICAL SKIN CLOSURE DEVICE

    MDR report key: 6899100 · Received September 27, 2017

    Report

    Report Number
    3009673389-2017-00007
    Event Type
    Injury
    Date Received
    September 27, 2017
    Date of Event
    August 2, 2017
    Report Date
    August 16, 2017
    Manufacturer
    ZIPLINE MEDICAL
    Product Code
    KGX
    PMA / PMN Number
    510K EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT COULD NOT BE CONFIRMED, AS THE SUSPECT DEVICE WAS DISCARDED BY THE PHYSICIAN AND NO PHOTOGRAPHIC IMAGES WERE PROVIDED FOR REVIEW. MULTIPLE ATTEMPTS WERE MADE BY THE ZIPLINE SALES REPRESENTATIVE TO DISCUSS THE CASE WITH THE PHYSICIAN; HOWEVER, THE PHYSICIAN HAS ELECTED NOT TO PARTICIPATE IN FURTHER DISCUSSION OF THE CASE. DURING FOLLOW-UP DISCUSSION BETWEEN ZIPLINE QUALITY ASSURANCE PERSONNEL AND THE ZIPLINE SALES REPRESENTATIVE, THE FOLLOWING WAS INDICATED: THE PHYSICIAN BELIEVES THAT THE BLEEDING WAS CAUSED BY THE PATIENT DURING RECOVERY/REHABILITATION. THE REPORTED FAILURE MODE OF "BROKEN OR DETACHED" ZIP DEVICE STRAPS WAS INCORRECT AND, PER THE ZIPLINE SALES REPRESENTATIVE, WAS ACTUALLY LOSS OF ADHESION OF THE ZIP DEVICE BASE TO THE PATIENT'S SKIN THAT MAY HAVE BEEN INITIATED BY REMOVAL OF THE WOUND DRESSING WHEN THE PATIENT PRESENTED TO CLINIC WITH THE BLEED. (CORRECTION) FOLLOWING INTERVENTION BY THE PHYSICIAN, WHICH CONSISTED OF REMOVAL OF THE ZIP DEVICE AND RE-CLOSURE OF THE INCISION, NO FURTHER COMPLICATIONS WERE REPORTED.

    Additional Manufacturer Narrative · 1

    EVALUATION OF EVENT HAS NOT YET BEEN POSSIBLE, AS AFFECTED DEVICE WAS DISCARDED BY PHYSICIAN UPON REMOVAL AND WILL NOT BE DELIVERED TO MANUFACTURER FOR ANALYSIS. IN ADDITION, NO PHOTOGRAPHIC IMAGES HAVE BEEN PROVIDED FOR ANALYSIS. MULTIPLE REQUESTS FOR CONTACT WITH PHYSICIAN HAVE BEEN MADE BY THE ZIPLINE SALES REPRESENTATIVE, BUT THE PHYSICIAN HAS NOT YET BEEN AVAILABLE FOR COMMUNICATION.

    Description of Event or Problem · 1

    FOLLOWING PLACEMENT OF TWO (2) ZIP SURGICAL SKIN CLOSURE DEVICES FOR CLOSURE OF A TOTAL KNEE ARTHROSCOPY INCISION, THE PATIENT COMPLAINED OF EXCESSIVE BLEEDING IN KNEE FLEXION ON POST-OPERATIVE DAY (POD) 1 AND 2. PATIENT REPORTED TO CLINIC FOR A DRESSING CHANGE, DURING WHICH THE PHYSICIAN'S MEDICAL ASSISTANT NOTED THAT 2 STRAPS WERE "BROKEN OR DETACHED" AND BLEEDING OCCURRED UNDER THAT REGION OF THE ZIP DEVICE. ON POD 3, THE PATIENT RETURNED TO THE CLINIC REPORTING THAT THE BLEEDING HAD NOT CEASED. THE PATIENT WAS THEN RE-ADMITTED ON POD 6 FOR REMOVAL OF THE ZIP DEVICES AND CLOSURE OF THE WOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    677996 ZIP SURGICAL SKIN CLOSURE DEVICE TAPE BASED WOUND CLOSURE KGX ZIPLINE MEDICAL PS1160

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention