BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VLOC 90

    MDR report key: 21774614 · Received April 4, 2025

    Report

    Report Number
    1219930-2025-01570
    Event Type
    Malfunction
    Date Received
    April 4, 2025
    Date of Event
    March 12, 2025
    Report Date
    April 10, 2025
    Manufacturer
    COVIDIEN LP LLC NORTH HAVEN
    Product Code
    GAM
    UDI-DI
    10884521803343
    PMA / PMN Number
    K100257
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    D10 CONCOMITANT PRODUCTS: VLOCM0335, SUTURE VLOCM0335 VLOC 90 2-0 VL 23 GS-21 (SN: (B)(6); VLOCM0335, SUTURE VLOCM0335 VLOC 90 2-0 VL 23 GS-21 (SN: (B)(6); VLOCM0335, SUTURE VLOCM0335 VLOC 90 2-0 VL 23 GS-21 (SN: (B)(6). 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

    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 REPORTER, DURING A UTERINE SUTURING AFTER A CAESAREAN SECTION, THE SUTURE WAS DAMAGED. IT WAS NOTED THAT FOUR SUTURES WAS USED AND HAD THE SAME ISSUE. THERE WAS NO PATIENT INJURY.

    Description of Event or Problem · 0

    ACCORDING TO THE REPORTER, DURING A UTERINE SUTURING AFTER A CAESAREAN SECTION, THE SUTURE BROKE WHILE IN USE. IT WAS NOTED THAT FOUR SUTURES WERE USED AND HAD THE SAME ISSUE. A NEW PRODUCT WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    687669 VLOC 90 SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC AC GAM COVIDIEN LP LLC NORTH HAVEN VLOCM0335 10884521803343

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown SEE H11.