BEUDAMED
    FDA Adverse Event Injury Summary report: N

    A&E MEDICAL 4.0 ROTATING SURGICAL PUNCH

    MDR report key: 11064862 · Received December 22, 2020

    Report

    Report Number
    MW5098498
    Event Type
    Injury
    Date Received
    December 22, 2020
    Date of Event
    October 22, 2020
    Report Date
    December 20, 2020
    Manufacturer
    A&E MEDICAL / ALTO DEVELOPMENT CORP.
    Product Code
    LRY
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    AORTIC PUNCH TIP FAILED TO RETRACT REQUIRING MANUAL REMOVAL WITH SURGICAL BLADE. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1525954 A&E MEDICAL 4.0 ROTATING SURGICAL PUNCH PUNCH, SURGICAL LRY A&E MEDICAL / ALTO DEVELOPMENT CORP. 4.0MM ROTATING SURGICAL PUNCH 00552

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention