BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GREATBATCH MEDICAL STEERABLE SHEATH

    MDR report key: 7718011 · Received July 25, 2018

    Report

    Report Number
    2183787-2018-00057
    Event Type
    Injury
    Date Received
    July 25, 2018
    Date of Event
    April 21, 2017
    Report Date
    July 12, 2018
    Manufacturer
    GREATBATCH MEDICAL
    Product Code
    DYB
    PMA / PMN Number
    K061119
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 1

    AS REPORTED SUMMARY THERE WAS NO ALLEGED PRODUCT ISSUE WITH THE GREATBATCH STEERABLE SHEATH. THE PRODUCT WAS NOT IN USE WHEN THE HEMATOMA WAS OBSERVED. CLINICAL FINDINGS WERE HEMATOMA IN INGUINAL REGION, INTENSE PAIN. HEMATOMA IS ASSOCIATED WITH PUNCTURE SITE AND ANTICOAGULATION WITH SINTROM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    561204 GREATBATCH MEDICAL STEERABLE SHEATH INTRODUCER, CATHETER DYB GREATBATCH MEDICAL 10876-002 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Other