BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIP 24 SURGICAL SKIN CLOSURE DEVICE

    MDR report key: 8524232 · Received April 17, 2019

    Report

    Report Number
    3009673389-2019-00003
    Event Type
    Injury
    Date Received
    April 17, 2019
    Date of Event
    March 12, 2019
    Report Date
    March 19, 2019
    Manufacturer
    ZIPLINE MEDICAL
    Product Code
    KGX
    UDI-DI
    00853114007232
    PMA / PMN Number
    510K EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    THE INITIAL REPORT DOCUMENTED THE PS1243 ZIPSEAL 24 SURGICAL SKIN CLOSURE CONVENIENCE KIT, WHICH CONSISTS OF THE PS1240 ZIP 24 SURGICAL SKIN CLOSURE DEVICE AND THE CARDINAL HEALTH TOPICAL SKIN ADHESIVE, AS THE SUSPECT MEDICAL DEVICE. BASED UPON THE VOLUNTARY EMDR REPORT NUMBER MW5085079 AND UPON FURTHER INVESTIGATION, THE REPORT HAS BEEN CORRECTED TO INDICATE THAT THE PS1240 ZIP 24 DEVICE IS THE SUSPECT MEDICAL DEVICE AND DOCUMENTS THE SKIN ADHESIVE AS A CONCOMITANT PRODUCT ONLY. ACCORDINGLY, THE FOLLOWING CHANGES WERE MADE TO FORM 3500A: D1: BRAND NAME: CHANGED TO ZIP 24 SURGICAL SKIN CLOSURE DEVICE. D2: TYPE OF DEVICE: CHANGED TO PRODUCT CODE KGX, WHICH IS ASSIGNED TO THE ZIP 24 SURGICAL SKIN CLOSURE DEVICE. D4: ADDITIONAL DEVICE INFORMATION: CHANGED MODEL NUMBER AND CATALOG NUMBER TO PS1240. UPDATED LOT NUMBER TO 0000110434. UPDATED EXPIRATION DATE TO MATCH EXPIRATION DATE OF THE ZIP DEVICE LOT. CHANGED UNIQUE DEVICE IDENTIFIER (UDI) ENTRY TO (B)(4) FOR THE ZIP DEVICE. D11: CONCOMITANT MEDICAL PRODUCTS AND THERAPY DATES: ADDED CARDINAL HEALTH TOPICAL SKIN ADHESIVE TO LIST. H4: DEVICE MANUFACTURER DATE: CHANGED DATE TO REFLECT MANUFACTURING DATE OF ZIP 24 LOT#: 0000110434.

    Additional Manufacturer Narrative · 1

    SEE USER FACILITY VOLUNTARY EMDR REPORT NUMBER MW5085079. ON POD 1, PATIENT SUFFERED A TRAUMATIC FALL, RESULTING IN FAILURE OF DEEP SUTURES AND SUBSEQUENT PARTIAL DEHISCENCE OF SURGICAL INCISION UNDER THE ZIP DEVICE. BASED UPON PATIENT PHOTOGRAPHIC IMAGE, THERE IS NO EVIDENCE OF DEVICE MALFUNCTION.

    Description of Event or Problem · 1

    TOTAL KNEE ARTHROPLASTY PATIENT WAS RE-ADMITTED TO OR FOR RE-CLOSURE OF SURGICAL INCISION FOLLOWING A TRAUMATIC FALL THAT RESULTED IN FAILURE OF DEEP SUTURES AND PARTIAL INCISION DEHISCENCE. SEE VOLUNTARY REPORT NUMBER MW5085079 GENERATED BY USER FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    316433 ZIP 24 SURGICAL SKIN CLOSURE DEVICE TAPE-BASED WOUND CLOSURE KGX ZIPLINE MEDICAL PS1240 0000110434 00853114007232

    Patients

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