BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UPJ OCCLUSION BALLOON CATHETER

    MDR report key: 12935216 · Received December 6, 2021

    Report

    Report Number
    1820334-2021-02638
    Event Type
    Malfunction
    Date Received
    December 6, 2021
    Date of Event
    November 24, 2021
    Report Date
    January 14, 2022
    Manufacturer
    COOK INC
    Product Code
    EZL
    UDI-DI
    00827002143371
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION HAS DETERMINED THE DEVICE PUSHED THROUGH THE SEAL OF THE DEVICE PACKAGING DURING SHIPMENT. THERE IS NO EVIDENCE TO SUGGEST THAT THIS DEVICE FAILURE WOULD BE LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR A SERIOUS INJURY IF THE FAILURE WERE TO RECUR. FURTHERMORE, THERE IS NO EVIDENCE THAT THE DEVICE CAUSED OR CONTRIBUTED TO A SERIOUS INJURY OR DEATH. AS SUCH, THE EVENT IS NOT REPORTABLE UNDER FDA 21 CFR PART 803 AS IT DOES NOT MEET THE CRITERIA FOR A DEATH, SERIOUS INJURY, OR REPORTABLE PRODUCT MALFUNCTION. 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

    OCCUPATION: OTHER NON-HEALTHCARE PROFESSIONAL: PROCUREMENT ASSISTANT. PMA/510K #: K183323. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.

    Description of Event or Problem · 0

    THERE IS NO NEW PATIENT OR EVENT INFORMATION TO REPORT.

    Description of Event or Problem · 0

    AS REPORTED, WHEN AN ORDER ARRIVED THE PACKAGING OF A UPJ OCCLUSION BALLOON CATHETER WAS OPEN ALREADY. THE PACKAGE /POUCH WAS NOT SEALED. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1833035 UPJ OCCLUSION BALLOON CATHETER EZL CATHETER, RETENTION TYPE, BALLOON EZL COOK INC G14337 14215632 00827002143371

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown