BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTIMA COIL SYSTEM

    MDR report key: 13389359 · Received January 28, 2022

    Report

    Report Number
    3014162263-2022-00005
    Event Type
    Malfunction
    Date Received
    January 28, 2022
    Date of Event
    August 27, 2021
    Report Date
    January 28, 2022
    Manufacturer
    BALT USA
    Product Code
    HCG
    UDI-DI
    00818053026096
    PMA / PMN Number
    K172390
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BALT USA REFERENCE COMPLAINT #(B)(4). THE UNIT WITH THE LABEL DISCREPANCY HAS BEEN RETURNED TO BALT USA UNDER RGA (B)(4). THIS COMPLAINT HAS TRIGGERED THE OPENING OF HHE-(B)(4) (BALT USA CO#(B)(4)) AND NCMR (B)(4) TO DRIVE COMPLETION OF THE HHE. ANY FURTHER CORRECTIVE ACTION AND INVESTIGATION WILL BE DOCUMENTED UNDER THE HHE AND NCMR. (B)(6) 2021: WHILE PREPARING HHE-(B)(4), THE INITIAL ASSESSMENT OF THIS COMPLAINT FILE WAS RE-EVALUATED DUE TO FEEDBACK RECEIVED FROM THE REGULATORY DEPARTMENT REGARDING THE HHE. UPON INITIAL ASSESSMENT, THE ASSUMPTION OF THE LABEL DISCREPANCY WAS MADE THAT THE SHELF CARTON LABEL WAS INCORRECT, AND THE POUCH LABEL WAS CORRECT ACCORDING TO THE LHR. AS RECORDED IN BALT USA NCMR (B)(4), ONE ADDITIONAL UNIT WAS RETURNED FROM BALT EXTRUSION UNDER RGA (B)(4) ((B)(6) 2021) AFTER THIS COMPLAINT HAD ALREADY BEEN CLOSED. AT THE TIME OF THE INITIAL ASSESSMENT, THE DEVICE POUCH WAS NOT OPENED KNOWING THAT THE UNIT HAD POTENTIAL TO BE REWORKED. DURING THE RE-EVALUATION OF THIS COMPLAINT, THE POUCH OF BOTH UNITS WERE OPENED AND THE LENGTH OF THE IMPLANT WAS FOUND TO BE 7CM, THEREFORE THE SHELF CARTON LABEL IS CORRECT AND THE POUCH LABEL IS INCORRECT. THIS ADDITIONAL EVALUATION HAS BEEN DOCUMENTED IN BALT USA NCMR (B)(4) AND HHE-(B)(4). (B)(6) 2022: INITIAL REPORTABILITY DECISION TREE DEEMED THIS EVENT AS NOT REPORTABLE. REPORTABILITY DECISION TREE WAS NOT UPDATED AFTER THE ADDITIONAL INFORMATION WAS RECEIVED REGARDING THIS INCIDENT. REPORTABILITY DECISION TREE HAS BEEN UPDATED AND HAS BEEN DEEMED REPORTABLE. NOTIFICATION OF URGENT FIELD SAFETY NOTICE (FSN) / PRODUCT RECALL WAS ISSUED 04JAN2022 WITH THE REFERENCE "FSN #: 3014162263-01/04/22-001-R" FOR INSIDE THE UNITED STATES. ADDITIONAL REFERENCE "(B)(4)_OPTIMA LABELING MIX-UP" USED FOR OUTSIDE THE UNITED STATES. FDA ACKNOWLEDGEMENT LETTER REFERENCE RES# (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT: "THEY SAY INSIDE DE EXTERNAL THE REFERENCE WAS DIFFERENT THAN THE ONE ON THE EXTERNAL BOX OUTSIDE CARD BOX LABEL OPTI0407CSF10 F210500135, INSIDE CONTAIN OPTI0204CSF10 DU LOT F210500134. PRODUCT WAS NOT USE AND POUCH REMAIN UN OPENED (CLOSED) WE CAN BRING BACK ALL BEFORE USE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1362349 OPTIMA COIL SYSTEM OPTIMA HCG BALT USA OPTI0407CSF10 F210500135 00818053026096

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other