BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROXIMATE SKIN STAPLER

    MDR report key: 3893896 · Received June 25, 2014

    Report

    Report Number
    3005075853-2014-04367
    Event Type
    Injury
    Date Received
    June 25, 2014
    Report Date
    June 3, 2014
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDT
    PMA / PMN Number
    K833357
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE WAS NOT RETURNED FOR EVALUATION. THE FOLLOWING INFORMATION WAS REQUESTED, BUT UNAVAILABLE: WHAT TYPES OF INCISIONS ARE BEING USED? WHAT KINDS OF SURGERIES ARE BEING PERFORMED? HOW MANY PATIENTS HAVE EXHIBITED THIS ISSUE? WHAT DAY POST OP ARE THE STAPLES COMING OUT? DID THE STAPLES FALL OUT? WHAT WAS THE SHAPE OF THE STAPLES WHEN THE EVENTS OCCURRED? HOW WAS THE ISSUE ADDRESSED/MITIGATED? WERE THERE EVENTS (FALLS, PHYSICAL ACTIVITY,¿) THAT LEAD TO THE STAPLE ISSUE? WHAT WAS THE SPACING BETWEEN STAPLES THAT WAS USED? WHERE ARE THE INCISIONS LOCATED? WHAT WAS THE SPACING BETWEEN STAPLES THAT WAS USED? ANY ISSUE WITH THE INITIAL APPLICATION OF THE STAPLES? WHAT WAS USED TO ADDITIONALLY SUPPORT THE STAPLES? STABILIZE THE WOUND? WHAT ARE THE PATIENT¿S BIOMETRIC DATA?

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENTS ARE CALLING THE DOCTORS AND STATING THAT THE STAPLES ARE FALLING OUT. THIS IS ALL THE INFORMATION AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    372033 PROXIMATE SKIN STAPLER REMOVABLE (SKIN) GDT ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1