BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPHERE INFLATION DEVICE

    MDR report key: 11567510 · Received March 25, 2021

    Report

    Report Number
    1820334-2021-01006
    Event Type
    Malfunction
    Date Received
    March 25, 2021
    Date of Event
    March 12, 2021
    Report Date
    May 3, 2021
    Manufacturer
    COOK INC
    Product Code
    KOE
    PMA / PMN Number
    K953522
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW-UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803 AND IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT CONTAINED HEREIN IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED, THAT A DEATH OR SERIOUS INJURY OCCURRED, NOR THAT ANY COOK DEVICE CAUSED, CONTRIBUTED TO, OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.

    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

    ADDITIONAL INFORMATION WAS RECEIVED 31MAR2021. A TOTAL OF THIRTY DEVICES WERE AFFECTED.

    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 (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, A WHITE POWDER WAS OBSERVED ON TWO SPHERE INFLATION DEVICES WITHIN THE DEVICE PACKAGING. THE DEVICE DID NOT MAKE PATIENT CONTACT AND WAS NOT USED DURING A PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    470147 SPHERE INFLATION DEVICE KOE COOK INC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1