BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMAJIN SILICONE HYDROGEL DOUBLE LOOP URETERAL STENT KIT

    MDR report key: 17633232 · Received August 28, 2023

    Report

    Report Number
    9610711-2023-00189
    Event Type
    Malfunction
    Date Received
    August 28, 2023
    Date of Event
    August 1, 2023
    Report Date
    April 16, 2024
    Manufacturer
    COLOPLAST A/S
    Product Code
    FAD
    UDI-DI
    03600040982426
    PMA / PMN Number
    K180469
    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 FOUND NONE CONCERNING LOT NUMBER 9127011. HOWEVER THIS ISSUE WAS KNOWN, A LABELLING ISSUE WAS OCCURED CONCERNING LABELLING AND TWO LOTS ARE INCRIMINATED ( 9127010 AND 9127011) A SIMILAR CASE STUDY WAS PERFORMED BASED ON THIS TWO ITEM, BCAG74 AND BCHG64 DEFECT LABELLING. FIVE SIMILAR CASES WERE FOUND ( (B)(4) ). A RESENSIBIILSATION WAS ALREADY DONE WITH COMPLAINT PREVIOUSLY REGISTERED ABOUT THIS LOT NUMBER. CHECKING THE QUALITY DATABASES REVEALED ONE CORRECTIVE AND PREVENTIVE ACTION AND ONE NON-CONFORMITY IN RELATION TO THE DESCRIBED DEFECT: - CAPA-00030 "QUALITY IMPROVEMENT 2023/2024": ALL THE OPERATORS OF THE DISTRIBUTION CENTER WERE TRAINED TO GOOD DISTRIBUTION PRACTICES IN JULY 2023. - NC-003375 "KITTING ISSUES IN LPP" OPENED ON DECEMBER 2023: THE ACTIONS ARE ONGOING.

    Additional Manufacturer Narrative · 0

    WITHOUT THE BENEFIT OF EXAMINATION AND TESTING, COLOPLAST IS PRECLUDED FROM COMMENTING ON THE CONDITION OF THE DEVICE OR THE CAUSE OF THE OCCURRENCE. SHOULD ADDITIONAL FACTS PROMPT US TO ALTER OR SUPPLEMENT ANY INFORMATION OR CONCLUSIONS CONTAINED IN THE ORIGINAL MDR OR IN ANY PRIOR SUPPLEMENTAL REPORTS, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    ACCORDING TO AVAILABLE INFORMATION, THE DEVICE DID NOT MATCH THE LABELING ON THE BOX. THE WRONG DEVICE MODEL BCHG64 WAS INSIDE THE BOX FOR THE BCAG64 DEVICE. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 0

    ACCORDING TO AVAILABLE INFORMATION, THE DEVICE DID NOT MATCH THE LABELING ON THE BOX. THE WRONG DEVICE MODEL BCHG64 WAS INSIDE THE BOX FOR THE BCAG64 DEVICE. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    285765 IMAJIN SILICONE HYDROGEL DOUBLE LOOP URETERAL STENT KIT UROLOGICAL SURGICAL PROCEDURE KIT, NON-MEDICATED, SINGLE USE FAD COLOPLAST A/S 9127011_BCHG643002 03600040982426

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown