BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNVISC ONE

    MDR report key: 7040178 · Received November 17, 2017

    Report

    Report Number
    2246315-2017-00187
    Event Type
    Malfunction
    Date Received
    November 17, 2017
    Date of Event
    November 1, 2017
    Report Date
    November 7, 2017
    Manufacturer
    GENZYME BIOSURGERY (RIDGEFIELD)
    Product Code
    MOZ
    PMA / PMN Number
    P940015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    (B)(4). THIS UNSOLICITED CASE FROM UNITED STATES WAS RECEIVED ON 07-NOV-2017 FROM THE OTHER NON HEALTH CARE PROFESSIONAL. THIS CASE CONCERNS A (B)(6) PATIENT (GENDER UNSPECIFIED) WHO RECEIVED TREATMENT WITH SYNVISC ONE INJECTION AND AFTER UNKNOWN LATENCY THE PATIENT EXPERIENCED SWELLING, HOT TO TOUCH, PAIN. NO RELEVANT MEDICAL HISTORY, PAST MEDICATIONS AND CONCOMITANT MEDICATIONS WERE REPORTED. ON (B)(6) 2017, THE PATIENT RECEIVED TREATMENT WITH INTRA-ARTICULAR SYNVISC ONE INJECTION, ONCE (LOT NUMBER: 7RSL021 AND DOSE, INDICATION, EXPIRATION DATE: NOT REPORTED). ON AN UNKNOWN DATE IN (B)(6) 2017, AFTER UNKNOWN LATENCY THE PATIENT EXPERIENCED SWELLING, HOT TO TOUCH, PAIN IN THE RIGHT. CORRECTIVE TREATMENT: UNSPECIFIED STEROID INJECTION FOR ALL. OUTCOME: UNKNOWN FOR ALL. A PHARMACEUTICAL TECHNICAL COMPLAINT (PTC) WAS INITIATED AND RESULTS WERE PENDING FOR THE SAME. SERIOUSNESS CRITERION: REQUIRED INTERVENTION FOR ALL

    Description of Event or Problem · 1

    THIS CASE WAS CROSS REFERENCED WITH (B)(4) (CLUSTER). THIS UNSOLICITED CASE FROM UNITED STATES WAS RECEIVED ON 07-NOV-2017 FROM THE OTHER NON HEALTH CARE PROFESSIONAL. THIS CASE CONCERNS A (B)(6) YEAR OLD PATIENT (GENDER UNSPECIFIED) WHO RECEIVED TREATMENT WITH SYNVISC ONE INJECTION AND AFTER UNKNOWN LATENCY THE PATIENT EXPERIENCED SWELLING, HOT TO TOUCH, PAIN; ALSO, DEVICE MALFUNCTION WAS IDENTIFIED FOR THE REPORTED LOT NUMBER. NO RELEVANT MEDICAL HISTORY, PAST MEDICATIONS AND CONCOMITANT MEDICATIONS WERE REPORTED. ON (B)(6) 2017, THE PATIENT RECEIVED TREATMENT WITH INTRA-ARTICULAR SYNVISC ONE INJECTION, ONCE (LOT NUMBER: 7RSL021 AND DOSE, INDICATION, EXPIRATION DATE: NOT REPORTED). ON AN UNKNOWN DATE IN (B)(6) -2017, AFTER UNKNOWN LATENCY THE PATIENT EXPERIENCED SWELLING, HOT TO TOUCH, PAIN IN THE RIGHT. CORRECTIVE TREATMENT: UNSPECIFIED STEROID INJECTION FOR ALL. OUTCOME: UNKNOWN FOR ALL THE EVENTS. A PHARMACEUTICAL TECHNICAL COMPLAINT (PTC) WAS INITIATED WITH GLOBAL PTC NUMBER: (B)(4). AN INVESTIGATION WAS INITIATED AS A RESULT OF AN UNEXPECTED INCREASE IN THE NUMBER OF LABELLED ADVERSE EVENTS RECEIVED FROM THE US MARKET FOR SYNVISC ONE LOT 7RSL021. THE PRODUCT MET ALL RELEASE TESTING AT TIME OF MANUFACTURE IN JUNE 2017. RETAIN SAMPLES WERE RETESTED DUE TO THE UNEXPECTED INCREASE IN ADVERSE EVENTS. HIGHER THAN EXPECTED ENDOTOXIN RESULTS WERE OBTAINED. IN ADDITION, THE PRESENCE OF MICROBIAL CONTAMINATION WAS ALSO CONFIRMED. THE CAUSE OF THESE EVENTS WAS UNDER INVESTIGATION. ONCE THIS INVESTIGATION WOULD BE COMPLETED, CORRECTIVE AND PREVENTIVE ACTIONS WOULD BE IMPLEMENTED. SERIOUSNESS CRITERION: NOT REPORTED FOR DEVICE MALFUNCTION AND REQUIRED INTERVENTION FOR OTHER EVENTS. FOLLOW UP INFORMATION WAS RECEIVED ON 16-NOV-2017. NO NEW INFORMATION RECEIVED. FOLLOW UP INFORMATION WAS RECEIVED ON 03-DEC-2017. NO NEW INFORMATION RECEIVED. ADDITIONAL INFORMATION WAS RECEIVED ON 22-NOV-2017. THE EVENT OF DEVICE MALFUNCTION WAS ADDED. GPTC RESULTS WERE ADDED AND TEXT AMENDED ACCORDINGLY. PHARMACOVIGILANCE COMMENT: SANOFI COMPANY COMMENT DATED 22-NOV-2017: THIS CASE CONCERNS A PATIENT WHO HAS RECEIVED SYNVISC ONE INJECTION FROM THE RECALLED LOT AND LATER THE PATIENT EXPERIENCED SWELLING, HOT TO TOUCH AND PAIN. A TEMPORAL RELATIONSHIP CAN BE ESTABLISHED WITH THE PRODUCT ADMINISTRATION. FURTHERMORE, THE CONCERNED LOT NUMBER HAS BEEN IDENTIFIED TO HAVE MALFUNCTION BY THE COMPANY. HENCE, THE CAUSAL RELATIONSHIP OF THE EVENTS TO THE PRODUCTS CANNOT BE EXCLUDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    821093 SYNVISC ONE INTRA-ARTICULAR HYALURONIC ACID MOZ GENZYME BIOSURGERY (RIDGEFIELD) 7RSL021

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention