BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHELON*FLEX60

    MDR report key: 1881515 · Received October 25, 2010

    Report

    Report Number
    1527736-2010-00079
    Event Type
    Injury
    Date Received
    October 25, 2010
    Date of Event
    April 9, 2010
    Report Date
    September 29, 2010
    Manufacturer
    ETHICON ENDO SURGERY, INC (CINCINNATI)
    Product Code
    GDW
    PMA / PMN Number
    K081146
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION. THE MATERIAL COMPOSITION FROM THE DEVICE WAS PROVIDED TO THE PATIENT.AS OF (B)(6) 2010, SHE IS CURRENTLY ON ORAL STEROIDS AND HAS BEEN FOR THE PAST FEW WEEKS; THE STEROIDS ARE WORKING. SHE HAS NOT UNDERGONE ANY ALLERGY TESTING AT THIS POINT AND IS UNSURE OF THE NEXT STEPS.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT THAT POST OP A GASTRIC BYPASS PROCEDURE; THE PATIENT EXPERIENCED AN ALLERGIC REACTION AND HAS REQUESTED THE STAPLE COMPOSITION FOR THE DEVICE. THE DATE OF SURGERY WAS (B)(6) 2010 AND SHORTLY THEREAFTER THE PATIENT HAD A RASH EVERYWHERE ON UPPER AND LOWER EXTREMITIES AND TRUNK. THE PATIENT HAS BEEN RECEIVING STEROID INJECTIONS, TOPICAL MEDICATION AND ALLERGY MEDICATIONS FROM THE DERMATOLOGIST. A COMPETITORS CIRCULAR STAPLER WAS USED DURING THE CASE AS WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECHELON*FLEX60 STAPLE, IMPLANTABLE GDW ETHICON ENDO SURGERY, INC (CINCINNATI) UNK UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other