BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICROPUNCTURE PUSH-PLUS TRANSITIONLESS INTRODUCER SET

    MDR report key: 1770173 · Received July 20, 2010

    Report

    Report Number
    1820334-2010-00362
    Event Type
    Injury
    Date Received
    July 20, 2010
    Report Date
    July 2, 2010
    Manufacturer
    COOK, INC.
    Product Code
    DYB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NO PRODUCT WAS RETURNED TO ASSIST IN THE INVESTIGATION. PER SPECIFICATION, IT IS CONFIRMED 100%, THAT THE SURFACE OF THE INNER AND OUTER CATHETERS ARE SMOOTH AND CLEAN, FREE OF EXCESSIVE DENTS AND KINKS. UNFORTUNATELY, AS NO PRODUCT WAS RETURNED AND BASED ON THE LIMITED INFORMATION PROVIDED, WE ARE UNABLE TO DETERMINE WITH CERTAINTY THE ROOT CAUSE OF THE REPORTED DIFFICULTY. HOWEVER, IT IS POSSIBLE THAT THE DESCRIBED DIFFICULTY WAS DUE TO THE PATIENT'S ANATOMY AND/OR CONDITION RATHER THAN THE FAULT OF THE DEVICE. WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS AND HAVE NOTIFIED THE APPROPRIATE PERSONNEL.

    Description of Event or Problem · 1

    ACCESS SITE BLEEDING (VISIBLE OOZING OR SPURTING) AFTER STANDARD COMPRESSION TIME. NO INFORMATION WAS PROVIDED REGARDING PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICROPUNCTURE PUSH-PLUS TRANSITIONLESS INTRODUCER SET DYB INTRODUCER, CATHETER DYB COOK, INC. NA 2488280

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other