BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROTACK

    MDR report key: 20566406 · Received October 30, 2024

    Report

    Report Number
    2647580-2024-04581
    Event Type
    Malfunction
    Date Received
    October 30, 2024
    Date of Event
    January 1, 2024
    Report Date
    October 30, 2024
    Manufacturer
    US SURGICAL PUERTO RICO
    Product Code
    GCJ
    UDI-DI
    10884521070400
    PMA / PMN Number
    K090470
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    D10 CONCOMITANT PRODUCT: 173054, 173054 ENDO UNI 12 WITH (LOT#P8J1316X); 174015, 174015 MF ENDO HERNIA DLU 4.0MM X6 (LOT#P8H1367X); HRA6, UNIVERSAL RETURN ELECTRODE HRA6 (LOT#9057X), MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    ACCORDING TO THE REPORTER, THE PATIENT EXPERIENCED URINARY TRACT INFECTION, BLOOD IN THE URINE, PAIN IN THE LOWER ABDOMEN, AND IT WAS NO LONGER POSSIBLE TO HAVE SEXUAL INTERCOURSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1020454 PROTACK LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ US SURGICAL PUERTO RICO 174006 P9A1273PY 10884521070400

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown PLEASE SEE NOTE ON H11.