BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DORMIA NO-TIP / N-STONE

    MDR report key: 18465901 · Received January 8, 2024

    Report

    Report Number
    9610711-2024-00011
    Event Type
    Injury
    Date Received
    January 8, 2024
    Date of Event
    December 7, 2023
    Report Date
    May 22, 2024
    Manufacturer
    COLOPLAST A/S
    Product Code
    FFL
    UDI-DI
    03600040268483
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AFTER RECEIVING THIS COMPLAINT, WE SEARCHED FOR OTHER COMPLAINTS AND WE FOUND NONE REGARDING THE LOT NUMBER 9252934. THE PRODUCT HAS BEEN MADE WITH FOLLOWING COMPONENTS: - SHEATH: ITEM NUMBER SVH151 LOT NUMBER 2111090221, - BASKET: ITEM NUMBER SS4149 LOT NUMBER 2303012106. CHECKING THE QUALITY DATABASE REVEALED NO ANOMALY IN RELATION TO THE DESCRIBED DEFECT. WITHOUT THE SAMPLE WE CANNOT DO MORE THAN A DOCUMENTARY INVESTIGATION WHICH REVEALED NO ANOMALY RECORDED DURING PRODUCTION. A SIMILAR CASE STUDY WAS DONE BASED ON SAME ITEM NUMBER AND SAME DEFECT (BROKEN) FROM DECEMBER 2019 TO DECEMBER 2023: 5 SIMILAR CASES WERE FOUND. A RMF [RISK MANAGEMENT FILE] EVALUATION WAS PERFORMED AND CONCLUDED THAT THE RESIDUAL RISKS ARE ADEQUATELY CONTROLLED AND REDUCED AS FAR AS POSSIBLE, AND THE RESIDUAL RISKS ASSOCIATED WITH THE USE OF THE PRODUCT ARE ACCEPTABLE WHEN WEIGHED AGAINST THE BENEFITS TO THE PATIENT/USER. IT IS CONCLUDED THAT THE RISKS IDENTIFIED ARE STILL ACCEPTABLE AND CONSIDERED AS SAFE. A CLINICAL ASSESSMENT WAS PERFORMED AND NO GENERAL CONCLUSION CAN BE DRAWN IN THE ABSENCE OF AN IDENTIFIED ROOT CAUSE OF THE SHEATH RUPTURE.

    Description of Event or Problem · 0

    ACCORDING TO THE AVAILABLE INFORMATION THE SHEATH AROUND THE DORMIA HAD FRAGMENTED. IT WAS REMOVED WITH FOREIGN BODY FORCEPS.

    Description of Event or Problem · 0

    THE DORMIA WAS BEING USED FOR PELVIC AND LUMBAR URETERAL STONES. ONE OF THE THREE STONES HAD ALREADY BEEN REMOVED WITH THE DORMIA PRIOR TO THE SHEATH ISSUE. FURTHER URETERORENOSCOPY WAS PERFORMED TO REMOVE THE STONES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    568896 DORMIA NO-TIP / N-STONE URINARY STONE RETRIEVAL BASKET, SINGLE USE FFL COLOPLAST A/S 9252934_EXN4341002 03600040268483

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention