BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GEL-ONE

    MDR report key: 7848552 · Received September 5, 2018

    Report

    Report Number
    9612392-2018-00015
    Event Type
    Injury
    Date Received
    September 5, 2018
    Report Date
    August 9, 2018
    Manufacturer
    SEIKAGAKU CORPORATION
    Product Code
    MOZ
    PMA / PMN Number
    P080020
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS CASE IS RECEIVED BY SEIKAGAKU CORPORATION ON AUGUST 14, 2018. SEIKAGAKU CORPORATION IS ALSO SUBMITTING THIS REPORT ON BEHALF OF ZIMMER, INC. AS THE IMPORTER WITH AUTHORIZATION BY THE EXEMPTION NUMBER E2011015.

    Additional Manufacturer Narrative · 0

    THIS CASE IS RECEIVED BY SEIKAGAKU CORPORATION ON AUGUST 14, 2018 AND ADDITIONAL INFORMATION PROVIDED BY THE INJECTION PHYSICIAN (NURSE PRACTITIONER) WAS FORWARDED TO US ON SEPTEMBER 11, 2018. MANUFACTURER ASSURED THAT THERE WAS NO QUALITY PROBLEM BASED ON THE MANUFACTURING PROCESS, THE IN-PROCESS TESTING, THE RELEASE TESTING AND THE ENVIRONMENTAL MONITORING FOR LOT NO. 0017Z19G. SEIKAGAKU CORPORATION IS ALSO SUBMITTING THIS REPORT ON BEHALF OF ZIMMER, INC. AS THE IMPORTER WITH AUTHORIZATION BY THE EXEMPTION NUMBER E2011015.

    Description of Event or Problem · 0

    ON 2018-UNK - AN (B)(6) MALE PATIENT HAD AN INTRA-ARTICULAR KNEE INJECTION OF GEL-ONE. SUBSEQUENTLY HE DEVELOPED AN ANAPHYLACTIC REACTION INCLUDING ITCHING AND TONGUE SWELLING. HE REQUIRED AN OVERNIGHT STAY IN INTENSIVE CARE. ON (B)(6) 2018, HE DID WELL.

    Description of Event or Problem · 0

    2018-UNK: AN 80 YEAR-OLD MALE PATIENT HAD AN INTRA-ARTICULAR KNEE INJECTION OF GEL-ONE. SUBSEQUENTLY HE DEVELOPED AN ANAPHYLACTIC REACTION INCLUDING ITCHING AND TONGUE SWELLING. HE REQUIRED AN OVERNIGHT STAY IN INTENSIVE CARE. ON (B)(6) 2018: HE DID WELL. FOLLOWING UP. BELOW IS A QUOTED EMAIL FROM THE ADMINISTERING PHYSICIAN (NURSE PRACTITIONER; NP): "CHRONOLOGY- NP ADMINISTERED THE INJECTION WITHOUT DIFFICULTY. THE PATIENT (PT) SAT IN THE EXAM TABLE FOR 5 MINUTES OR SO & GOT UP & WALKED OUT OF OFFICE WITHOUT PROBLEM. NP RECEIVED A PHONE CALL APPROXIMATELY 2 HOURS LATER FROM PT. PT WAS DRIVING TO THE ER & REPORTED TONGUE SWELLING & ITCHING IN PT'S ARMPITS, GROIN & FINGERS. PT WAS UNSURE IF PT HAD A RASH. PT WAS SPEAKING VERY CLEARLY & DID NOT SOUND STRESSED. NP ASKED IF SOMEONE ELSE SHOULD DRIVE PT BUT PT SAID NO, PT WAS FINE TO DRIVE & ALMOST TO THE HOSPITAL. PT ATE AT MCDONALD'S THAT MORNING, NO NEW FOOD. NO NEW MEDICATION TAKEN THAT MORNING. NP ASKED PT TO CALL US BACK LATER THAT AFTERNOON TO REPORT PT'S CONDITION. NP BELIEVES THE ER DOCTOR CALLED DR. KNIGHT WHEN PT WAS ADMITTED. NP HAD NO PROBLEM INJECTING THE GEL-ONE TO THE AMTERIOMEDIAL ASPECT OF PT'S LEFT KNEE. PT HAD NO ADVERSE EFFECTS WHILE STILL IN THE OFFICE. PT FOLLOWED UP WITH AN APPOINTMENT WITH DR. (B)(6) ON (B)(6)."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    690269 GEL-ONE ACID, HYALURONIC, INTRAARTICULAR MOZ SEIKAGAKU CORPORATION 00-1111-001-00 0017Z19G

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Hospitalization