BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO UNIVERSAL 65

    MDR report key: 20025919 · Received August 22, 2024

    Report

    Report Number
    2647580-2024-03654
    Event Type
    Injury
    Date Received
    August 22, 2024
    Date of Event
    January 4, 2024
    Report Date
    August 22, 2024
    Manufacturer
    US SURGICAL PUERTO RICO
    Product Code
    GCJ
    UDI-DI
    10884521070530
    PMA / PMN Number
    K912097
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: G3, LITERATURE FILE ATTACHED 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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Additional Manufacturer Narrative · 0

    D10 CONCOMITANT PRODUCTS: 173054, 173054 ENDO UNI 12 WITH (LOT#:UNKNOWN) FERDINAND, KÖCKERLING MD. "HERNIAMED REGISTRY EXTRACTION MEDTRONIC ENDO UNIVERSAL 65 IN ELECTIVE LAPAROSCOPIC INGUINAL, UMBILICAL, EPIGASTRIC AND INCISIONAL HERNIA REPAIR (1-YEAR FOLLOW-UP)", ISSUE V00, 04JAN2024. 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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    ACCORDING TO THE LITERATURE SOURCE OF STUDY, A RETROSPECTIVE STUDY OUTCOME OF THE EVALUATION OF THE SAFETY AND PERFORMANCE OF MEDTRONIC ENDO UNIVERSAL 65 IN ELECTIVE LAPAROSCOPIC INGUINAL, UMBILICAL, EPIGASTRIC AND INCISIONAL HERNIA OPERATIONS (1 YEAR FOLLOW-UP). 1.351 (92.28 %) PATIENTS IN ELECTIVE LAPAROSCOPIC INGUINAL HERNIA REPAIR, 36 (2.46 %) PATIENTS IN ELECTIVE LAPAROSCOPIC UMBILICAL HERNIA REPAIR, 7 (0.48 %) PATIENTS IN ELECTIVE LAPAROSCOPIC EPIGASTRIC HERNIA REPAIR AND 70 (4.78 %) PATIENTS IN ELECTIVE LAPAROSCOPIC INCISIONAL HERNIA REPAIR WERE INCLUDED IN THE STUDY. TISSUE BREAKDOWN (INTRAOPERATIVE ORGAN INJURIES) IS A COMPLICATION. POST OPERATIVE COMPLICATIONS INCLUDED BLEEDING, SEROMA, INFECTION, PAIN AND HERNIA RECURRENCE ARE DEVICE RELATED. ADDITIONAL SURGERY WAS REQUIRED. GENERAL COMPLICATIONS AND COMPLICATION RELATED REOPERATIONS ARE NOT RELATED TO THE DEVICE. HERNIAMED REGISTRY EXTRACTION MEDTRONIC ENDO UNIVERSAL 65 IN ELECTIVE LAPAROSCOPIC INGUINAL, UMBILICAL, EPIGASTRIC AND INCISIONAL HERNIA OPERATIONS (1 YEAR FOLLOW-UP), DR. (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1014942 ENDO UNIVERSAL 65 LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ US SURGICAL PUERTO RICO 173054 10884521070530

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention SEE H11.