BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE** PLUS MD MULTI-DIRECTIONAL RELEASE SKIN STAPLER - 35 REGULAR

    MDR report key: 3173263 · Received June 17, 2013

    Report

    Report Number
    1527736-2013-00014
    Event Type
    Malfunction
    Date Received
    June 17, 2013
    Date of Event
    May 25, 2013
    Report Date
    June 4, 2013
    Manufacturer
    ETHICON ENDO SURGERY, INC (CINCINNATI)
    Product Code
    GDT
    PMA / PMN Number
    K833357
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION WAS NOT PROVIDED BY CONTACT. INFORMATION UNAVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE SOCIAL SERVICES DEPARTMENT OF (B)(6) THAT ON (B)(6) 2013, A CHILD HAD TWO SKIN STAPLES PLACED BY HER MOTHER IN A LACERATION ON THE HEAD FROM A FALL. THE MOTHER OF THE CHILD CLAIMS TO HAVE USED A PROXIMATE ROTATING HEAD SKIN STAPLER SHE OBTAINED FROM HER FIRST AID KIT, WITHOUT TAKING THE CHILD TO A MEDICAL FACILITY. ON (B)(6) 2013, THE FATHER OF THE CHILD HAD VISITATION WITH THE CHILD AND BECAME AWARE OF THE STAPLES IN THE CHILD¿S HEAD. THE FATHER TOOK THE CHILD TO THE DOCTOR AND THE STAPLES WERE REMOVED. THE DOCTOR SAID THE STAPLES WERE NOT PROPERLY HOLDING THE WOUND TOGETHER AND THAT THEY WERE NOT MEDICAL GRADE STAPLES. THE WOUND APPEARED TO BE HEALING AND NO FURTHER TREATMENT WAS REQUIRED. SPOKE WITH THE CASE WORKED IN AN ATTEMPT TO OBTAIN ADDITIONAL INFORMATION AND WAS INFORMED THAT DUE TO PATIENT AND FAMILY PRIVACY, NO FURTHER INFORMATION CAN BE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274385 PROXIMATE** PLUS MD MULTI-DIRECTIONAL RELEASE SKIN STAPLER - 35 REGULAR REMOVABLE (SKIN) GDT ETHICON ENDO SURGERY, INC (CINCINNATI) UNK UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR