BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNSPECIFIED HA FILLER

    MDR report key: 8420189 · Received March 14, 2019

    Report

    Report Number
    9710154-2019-00006
    Event Type
    Injury
    Date Received
    March 14, 2019
    Report Date
    March 13, 2019
    Manufacturer
    GALDERMA Q-MED
    Product Code
    LMH
    PMA / PMN Number
    P040024
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER NARRATIVE: LOT NUMBER WAS NOT REPORTED. PHARMACOVIGILANCE COMMENT: THE SERIOUS EVENT OF FOREIGN BODY GRANULOMA WAS CONSIDERED EXPECTED AND POSSIBLY RELATED TO THE TREATMENT. SERIOUS CRITERIA INCLUDED THE NEED FOR SURGICAL RESECTION. THE SUSPECT PRODUCT WAS REPORTED AS AN UNSPECIFIED HYALURONIC ACID FILLER; HOWEVER, WE CANNOT EXCLUDE THAT ONE OF OUR HYALURONIC ACID FILLER PRODUCTS HAVE BEEN USED. THE CASE MEETS THE SERIOUSNESS CRITERIA FOR EXPEDITED REPORTING TO THE REGULATORY AUTHORITIES. CAPA COMMENT: THE INFORMATION IN THIS SINGLE CASE DOES NOT SUGGEST INVOLVEMENT OF A NONCONFORMING PRODUCT OR QUALITY PROBLEM AND WILL NOT INITIATE A CORRECTIVE OR PREVENTIVE ACTION. EXEMPTION: GALDERMA LABORATORIES L.P. IS SUBMITTING THIS REPORT ON BEHALF OF Q-MED AB. EXEMPTION NUMBER E2015005 - ATTACHMENT: [LRE-190005(RE-190001).PDF, LRE-190005(TRANSLATION).PDF]

    Description of Event or Problem · 0

    CASE REFERENCE NUMBER (B)(4) IS A SPONTANEOUS,LITERATURE REPORT SENT ON 05-MAR-2019. TANABE M, ET AL. "A CASE OF FOREIGN BODY GRANULOMA IN THE EYE CAUSED BY HYALURONIC ACID." THE 30TH ANNUAL MEETING OF JAPAN SOCIETY OF EYE LID AND EYE SOCKET SURGERY. 2019: 27. THIS LITERATURE CASE DESCRIBES THE FOLLOWING CASE: [INTRODUCTION]: HYALURONIC ACID, A KIND OF FILLING MATERIAL (FILLER) USED FOR COSMETIC PURPOSES, IS A COMPONENT PRESENT WIDELY IN THE BODY. THUS, HYALURONIC ACID IS CONSIDERED TO BE RELATIVELY SAFE, BUT IT INFREQUENTLY CAUSES COMPLICATIONS SUCH AS BLEEDING SPOT, SWELLING, ABSCESS, FOREIGN BODY GRANULOMA, AND SCAR. [CASE]: THE PATIENT WAS A (B)(6) FEMALE. THE PATIENT VISITED THE AUTHOR'S DEPARTMENT WITH A CHIEF COMPLAINT OF A MASS IN THE LEFT LOWER ORBITAL RIM, WHICH SHOWED AN INCREASING TENDENCY OVER THE LAST 3 WEEKS. A HARD MASS WAS PALPABLE ON THE ANTERIOR SURFACE OF THE ORBITAL BONE. A MAGNETIC RESONANCE IMAGING (MRI) WITH GADOLINIUM CONTRAST ENHANCEMENT SHOWED A MASS OF APPROXIMATELY 24 X 8 X 8 MM IN SIZE WHICH WAS FAINTLY ENHANCED AND RELATIVELY UNIFORMED ON THE IMAGE. TOTAL RESECTION OF THE MASS WAS PERFORMED PERCUTANEOUSLY. HISTOPATHOLOGICAL EXAMINATION SHOWED AGGREGATION OF GIANT CELLS WHICH PHAGOCYTOSED EOSINOPHILIC AMORPHOUS SUBSTANCES, AND GRANULOMA FORMATION SURROUNDED BY HISTIOCYTES, EOSINOPHILS AND LYMPHOCYTES. FOREIGN BODY GRANULOMA DUE TO HYALURONIC ACID INJECTION WAS SUSPECTED, AND THE PATIENT WAS INTERVIEWED AGAIN. THEN THE PATIENT REPORTED THAT THE PATIENT RECEIVED HYALURONIC ACID INJECTION 6 MONTHS BEFORE FOR THE COSMETIC PURPOSE. AFTER THE RESECTION, NO RECURRENCE WAS NOTED AND THE COURSE WAS FAVORABLE. [CONCLUSION]: PATIENTS WITH LONG TIME INTERVAL FROM WHEN RECEIVING THE HYALURONIC ACID INJECTION, LIKE THE PATIENT IN THIS CASE, USUALLY DO NOT SUSPECT THE CAUSAL RELATIONSHIP TO THE INJECTION BY THEMSELVES. HOWEVER, IF A MASS LESION WAS OBSERVED IN THE FILLER INJECTION SITES IN THE FACE, ESPECIALLY IN THE LATERAL CANTHUS, LOWER ORBITAL RIM, AND NASOLABIAL FOLD, IT IS CONSIDERED IMPORTANT TO PERFORM THOROUGH HISTORY TAKING WITH FOREIGN BODY GRANULOMA IN MIND AS A DIFFERENTIAL DIAGNOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    216081 UNSPECIFIED HA FILLER IMPLANT, DERMAL, FOR AESTHETIC USE LMH GALDERMA Q-MED

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention