BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA

    MDR report key: 17531805 · Received August 12, 2023

    Report

    Report Number
    MW5138716
    Event Type
    Injury
    Date Received
    August 12, 2023
    Report Date
    April 1, 2022
    Manufacturer
    ABIOMED
    Product Code
    OJE
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    HEMATOMA OVER IMPELLA SITE AT RIGHT AXILLARY, POST-PROCEDURE. : EXPLORATION OF RIGHT CHEST WALL IMPELLA WOUND. CULTURES OBTAINED. WOUND WASHED OUT AND VAC DRESSING APPLIED NOTE STATES R PECTORALIS INTRAMUSCULAR HEMATOMA WO DISCRETE ABSCESS IDENTIFIED. (B)(4). THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1050557 IMPELLA RIGHT VENTRICULAR BYPASS (ASSIST) DEVICE OJE ABIOMED LMPELLA DEVICE

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown