BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JACOBSON PETITPOINT MOSQ 5 CVD

    MDR report key: 11735358 · Received April 27, 2021

    Report

    Report Number
    2523190-2021-00075
    Event Type
    Malfunction
    Date Received
    April 27, 2021
    Date of Event
    March 4, 2021
    Report Date
    June 4, 2021
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION OH/USA
    Product Code
    HRQ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    105089 JACOBSON PETITPOINT MOSQ WAS NOT RETURNED FOR EVALUATION AND LOT NUMBER INFORMATION HAS NOT BEEN PROVIDED; THEREFORE, AN EVALUATION OF THE DEVICE COULD NOT BE PERFORMED, AND MANUFACTURING RECORDS COULD NOT BE REVIEWED. THREE ATTEMPTS HAVE BEEN MADE TO RETRIEVE THE PRODUCT. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE, THIS COMPLAINT WILL BE REOPENED, AND THE RESPECTIVE EVALUATION PERFORMED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR ISSUES. AT PRESENT, WE CONSIDER THIS COMPLAINT TO BE CLOSED.

    Description of Event or Problem · 0

    N/A.

    Additional Manufacturer Narrative · 1

    ATTEMPTS ARE BEING MADE TO OBTAIN ADDITIONAL INFORMATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A MEDWATCH FORM WITH UF/ IMPORTER REPORT # (B)(4) WAS RECEIVED ON 30MAR2021 WITH THE FOLLOWING INFORMATION: DURING A VASCULAR PROCEDURE, APPROXIMATELY 3MM TIP OF JACOBSON MOSQUITO CLAMP (PRODUCT ID 105089) BROKE OFF. THE TIP WAS INITIALLY RETRIEVED BUT THEN LOST. IT IS UNKNOWN IF THERE WAS PATIENT INJURY OR SURGERY DELAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    632033 JACOBSON PETITPOINT MOSQ 5 CVD N/A HRQ INTEGRA LIFESCIENCES CORPORATION OH/USA 1002181403

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR