BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 2873862 · Received December 14, 2012

    Report

    Report Number
    1527736-2012-00031
    Event Type
    Injury
    Date Received
    December 14, 2012
    Report Date
    November 27, 2012
    Manufacturer
    ETHICON ENDO SURGERY, INC (CINCINNATI)
    Product Code
    GDT
    PMA / PMN Number
    K833357
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): INFORMATION UNAVAILABLE. THE DEVICE WAS NOT RETURNED. DEVICE LOCATION UNKNOWN.

    Description of Event or Problem · 1

    THE PATIENT CLAIMS TO HAVE ADVISED THE SURGEON OF BEING ALLERGIC TO METALS PRIOR TO THE SURGERY. THE PLAN IS TO PERFORM ALLERGY TESTING AND WILL PROCURE A STAPLE FOR THE TESTING. IT WAS REPORTED THAT THE PATIENT HAD REDNESS AND ITCHING AND IS NOT CLEAR OF WHAT, IF ANY TREATMENT WAS PROVIDED AS THE SYMPTOMS RESOLVED AFTER THE STAPLES WERE REMOVED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other