BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPHERE INFLATION DEVICE

    MDR report key: 11574864 · Received March 26, 2021

    Report

    Report Number
    1820334-2021-01022
    Event Type
    Malfunction
    Date Received
    March 26, 2021
    Date of Event
    March 18, 2021
    Report Date
    May 4, 2021
    Manufacturer
    COOK INC
    Product Code
    KOE
    UDI-DI
    10827002310275
    PMA / PMN Number
    K953522
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED AS A CORRECTION. UPON FURTHER REVIEW, IT HAS BEEN DETERMINED THAT ATRION IS THE LABELED MANUFACTURER OF THE COMPLAINT DEVICE AND IS THEREFORE RESPONSIBLE FOR ALL REGULATORY REPORTING AND COMPLAINT INVESTIGATION REQUIREMENTS. THE COMPLAINT INFORMATION HAS BEEN PROVIDED TO THE MANUFACTURER (ATRION) AND ENTERED IN THE COMPLAINT FILE BY COOK INC.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

    Additional Manufacturer Narrative · 1

    COMMON NAME & PRODUCT CODE- PTM, KOE. NAME AND ADDRESS: (B)(6). THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW-UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.

    Description of Event or Problem · 1

    AS REPORTED, PRIOR TO AN UNKNOWN PROCEDURE THE USER OPENED A SPHERE INFLATION DEVICE AND FOUND A WHITE FOREIGN SUBSTANCE ON THE DEVICE. THE USER THEN WIPED THE DEVICE WITH GAUZE AND USED IT TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE EFFECTS TO THE PATIENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    475443 SPHERE INFLATION DEVICE KOE COOK INC 96271A003 10827002310275

    Patients

    Seq Age Sex Outcome Treatment
    1