BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CURAPLEX

    MDR report key: 9774578 · Received February 28, 2020

    Report

    Report Number
    MW5093396
    Event Type
    Injury
    Date Received
    February 28, 2020
    Date of Event
    February 26, 2020
    Report Date
    February 26, 2020
    Manufacturer
    BOUND TREE MEDICAL, LLC
    Product Code
    CAE
    UDI-DI
    00817617020549
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    CURAPLEX SUPRAGLOTIC AIRWAY KIT, KING LTS-D, SIZE 2.5, 25-35KG #477-KLTSD4125 (LOT #ASM0021574) CONTAINS: (1) SUPRAGLOTIC AIRWAY, KING LTS-D SIZE 2.5 (1) SYRINGE ONLY, 10 OC LUER LOCK (1) GASTRIC TUBE, 16FR (1) PACKET OF LUBRICATING JELLY. THE MANUFACTURER (AMBU) OF THE KING AIRWAY LTS-D RECOMMENDS AN INFLATION VOLUME OF 30-40 CC FOR THE DEVICE AND THE PACKAGED PRODUCT FROM THE MANUFACTURER COMES WITH A SYRINGE SIZED TO SUPPORT THIS VOLUME. THE 10 CC SYRINGE FOUND IN THE CURAPLEX KIT WITH THE SAME KING AIRWAY DEVICE COULD RESULT IN AN UNDER-INFLATED BALLOON IF THE USER DOES NOT RE-LOAD THE SYRINGE WITH AIR 3-4 TIMES. AN UNDER-INFLATED BALLOON COULD LEAD TO DEVICE FAILURE RESULTING IN HYPOXIA AND IF UNTREATED DEATH. CURAPLEX PRODUCT BY SAMOVA HC. LLC'S FAMILY OF COMPANIES: BOUND TREE MEDICAL LLC. CARDIC PARTNERS, INC. EMERGENCY MEDICAL PRODUCTS, INC. & TRI-ANIM HEALTH SERVICES INC. DISTRIBUTOR: (B)(4). FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    230992 CURAPLEX AIRWAY, OROPHARYNGEAL, ANESTHESIIOLOGY CAE BOUND TREE MEDICAL, LLC #477KLTSD4125 ASM0021574 00817617020549

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability