BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUSTOM SPINAL PACK

    MDR report key: 8772272 · Received July 8, 2019

    Report

    Report Number
    MW5087943
    Event Type
    Injury
    Date Received
    July 8, 2019
    Date of Event
    June 20, 2019
    Report Date
    July 3, 2019
    Manufacturer
    AMERICAN CONTRACT SYSTEMS
    Product Code
    LRO
    UDI-DI
    00191072004109
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    HAIR FOUND ON BACK TABLE COVER OF CUSTOM SPINAL PACK. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    560050 CUSTOM SPINAL PACK GENERAL SURGICAL TRAY LRO AMERICAN CONTRACT SYSTEMS 880191 00191072004109

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention