BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN VLOC PRODUCT

    MDR report key: 21104193 · Received January 8, 2025

    Report

    Report Number
    1219930-2025-00145
    Event Type
    Injury
    Date Received
    January 8, 2025
    Date of Event
    September 27, 2024
    Report Date
    March 21, 2025
    Manufacturer
    COVIDIEN LP LLC NORTH HAVEN
    Product Code
    GAM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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.

    Additional Manufacturer Narrative · 0

    D10 CONCOMITANT PRODUCTS: UNKNOWN PROGRIP, UNKNOWN PROGRIP MESH PRODUCT (SERIAL#:UNK) (LOT#:UNK). ALEXANDROS VALORENZOS, KRISTIAN ALS NIELSEN, IHSAN INAN, ANDREAS KRISTIAN PEDERSEN, SOFIE RONJA PETERSEN, MARK BREMHOLM ELLEBAEK, AYAT ALLAH ALNABHAN, PER HELLIGSØ, ALLAN DORFELT, MICHAEL FESTERSEN NIELSEN. "REDUCED RISK OF RECURRENCE FOLLOWING ROBOTIC-ASSISTED TAPP FOR INGUINAL HERNIA REPAIR COMPARED TO LAPAROSCOPIC TAPP: A COHORT STUDY OF 395 CASES", 2024, HERNIA (2025) 29:33. HTTPS://DOI.ORG/10.1007/S10029-024-03226-2. 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.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: B5, G3, H6. ADDITIONAL INFORMATION RECEIVED SHOWS THAT THERE IS NO INFORMATION TO REASONABLY SUGGEST THAT THE DEVICE IN THIS REPORT MAY HAVE CAUSED OR CONTRIBUTED TO A DEATH OR SERIOUS INJURY OR THAT THE DEVICE IN THIS REPORT HAS MALFUNCTIONED. THEREFORE, THIS EVENT DOES NOT MEET THE REPORTING REQUIREMENTS IN 21 CFR 803. 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, A RETROSPECTIVE STUDY WAS CONDUCTED BETWEEN 2017 AND 2019 INVOLVING 395 CASES OF LAPAROSCOPIC TRANSABDOMINAL PREPERITONEAL (TAPP) PROCEDURE OR ROBOTIC-ASSISTED TAPP (R-TAPP) FOR INGUINAL HERNIA REPAIR. THE SELF-FIXATING MESH WAS USED IN THE R-TAPP PROCEDURE AND THE PERITONEUM WAS CLOSED USING A 2-0 V-LOC SUTURE. BRANDED MESH, FIXATION DEVICES, OR SUTURE WERE NOT MENTIONED IN THE TAPP PROCEDURE DESCRIPTION. COMPLICATIONS IN BOTH GROUPS INCLUDE HEMATOMA AND HERNIA RECURRENCE. NO INTERVENTIONS ARE MENTIONED. OTHER NON-DEVICE RELATED COMPLICATIONS INCLUDED CHRONIC PAIN AND WOUND INFECTIONS. ARTICLE: MICHAEL FESTERSEN NIELSEN, HERNIA (2025) 29:33. HTTPS://DOI.ORG/10.1007/S10029-024-03226-2.

    Description of Event or Problem · 0

    ACCORDING TO THE LITERATURE, A RETROSPECTIVE STUDY WAS CONDUCTED BETWEEN 2017 AND 2019 INVOLVING 395 CASES OF LAPAROSCOPIC TRANSABDOMINAL PREPERITONEAL (TAPP) PROCEDURE OR ROBOTIC-ASSISTED TAPP (R-TAPP) FOR INGUINAL HERNIA REPAIR. THE SUTURE WAS USED CONSISTENTLY TO CLOSE THE PERITONEUM. COMPLICATIONS IN BOTH GROUPS INCLUDE HEMATOMA AND HERNIA RECURRENCE. NO INTERVENTIONS ARE MENTIONED. OTHER NON-DEVICE RELATED COMPLICATIONS INCLUDED CHRONIC PAIN AND WOUND INFECTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1321484 UNKNOWN VLOC PRODUCT SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC AC GAM COVIDIEN LP LLC NORTH HAVEN UNKNOWN VLOC PRODUCT

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| O