BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYALURONIC ACID

    MDR report key: 7241037 · Received February 5, 2018

    Report

    Report Number
    9610200-2018-00001
    Event Type
    Injury
    Date Received
    February 5, 2018
    Report Date
    February 5, 2018
    Manufacturer
    FIDIA FARMACEUTICI S.P.A.
    Product Code
    MOZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2011017 ON 28 NOVEMBER 2011, THE FDA GRANTED THE PERMISSION FOR THE MANUFACTURER FIDIA FARMACEUTICI S.P.A. TO SUBMIT A SINGLE MDR FOR ADVERSE EVENTS THAT INVOLVE MEDICAL DEVICES MANUFACTURED BY FIDIA FARMACEUTICI S.P.A. AND IMPORTED INTO THE USA BY FIDIA PHARMA USA, INC. AS A CONSEQUENCE, FIDIA FARMACEUTICI S.P.A. (THE MANUFACTURER) IS SUBMITTING THIS REPORT EVEN ON BEHALF OF FIDIA PHARMA USA INC. (THE IMPORTER). THE PRESENT MDR REPORT SATISFIES THE REPORTING OBLIGATIONS FOR BOTH COMPANIES. THE CASE CAME FROM US LITERATURE. THE PATIENT AFTER THE OFF-LABEL USE (PHARYNGOPLASTY) OF A PRODUCT CONTAINING HYALURONIC ACID (SOLUTION FOR INJECTION), AS ACTIVE SUBSTANCE HAD RETROPHARYNGEAL ABSCESS (WITH THE FOLLOWING SYMPTOMS: ODYNOPHAGIA, NECK PAIN WITH LIMITED RANGE OF MOTION, HIGH FEVER AND LEUKOCYTOSIS). THE CASE HAS BEEN DEEMED AS SERIOUS DUE TO MEDICAL IMPORTANT EVENT. THE CASE HAS BEEN DEEMED AS SERIOUS/UNEXPECTED DUE TO THE REACTIONS RETROPHARYNGEAL ABSCESS AND OFF-LABEL USE WHICH ARE NOT LISTED IN THE INSERT PACKAGE LEAFLET OF THE PRODUCT. THE CAUSALITY RELATIONSHIP HAS BEEN EVALUATED AS PROBABLE BY THE COMPANY. NO NEW SIGNAL ALERT HAS BEEN DETECTED. SINCE IT IS NOT POSSIBLE TO EXCLUDE THAT THE PRODUCT BELONGS TO FIDIA, THE COMPANY IS GOING TO REPORT THE CASE TO HAS (EMA AND FDA). THE DEVICE IS NOT AVAILABLE.

    Description of Event or Problem · 0

    THIS IS AN AMERICAN CASE-REPORT FROM THE WORLDWIDE SCIENTIFIC LITERATURE MONITORING ON THE ACTIVE INGREDIENT "HYALURONIC ACID" (JOSEPH CAPO, S. N. HELMAN ET AL., RETROPHARYNGEAL ABSCESS AS A RESULT OF HYALURONIC ACID INJECTION PHARYNGOPLASTY: A FIRST OF ITS KIND. AMERICAN JOURNAL OF OTOLARYNGOLOGY-HEAD AND NECK MEDICINE AND SURGERY 38 (2017) 718-719). A (B)(6) MALE PRESENTED TO THE EMERGENCY DEPARTMENT AT OUR TERTIARY LEVEL INSTITUTION WITH ODYNOPHAGIA, NECK PAIN WITH LIMITED RANGE OF MOTION, HIGH FEVER AND LEUKOCYTOSIS. SIX DAYS PRIOR, HE UNDERWENT AUGMENTATION PHARYNGOPLASTY AT AN OUTSIDE TERTIARY CENTER. THE PATIENT APPEARED MILDLY UNCOMFORTABLE BUT WAS NOT IN RESPIRATORY DISTRESS. BEDSIDE NASOPHARYNGOSCOPY REVEALED BULGING OF THE POSTERIOR PHARYNGEAL WALL EXTENDING FROM THE NASOPHARYNX TO THE HYPOPHARYNX, CONCERNING FOR A RETROPHARYNGEAL ABSCESS. COMPUTED TOMOGRAPHY (CT) WITH CONTRAST OF THE NECK WAS SIGNIFICANT FOR A LARGE RETROPHARYNGEAL ABSCESS EXTENDING FROM THE NASOPHARYNX TO THE HYPOPHARYNX. IT WAS REVEALED THAT THE PATIENT'S SIBLING WAS DIAGNOSED WITH STREPTOCOCCAL THROAT INFECTION THREE DAYS PRIOR TO SURGERY AND THE PATIENT HAD BEEN COMPLAINING OF MILD, INTERMITTENT ODYNOPHAGIA. INTRAVENOUS ANTIBIOTICS WERE ADMINISTERED AND THE PATIENT WAS TAKEN EMERGENTLY TO THE OPERATING ROOM FOR INCISION AND DRAINAGE. COPIOUS PUS WAS DRAINED AND THERE WAS NO EVIDENCE OF RESIDUAL FILLER MATERIAL IN THE NASOPHARYNX. HE MADE A FULL RECOVERY AFTER A COURSE OF INTRAVENOUS AND ORAL ANTIBIOTICS BUT RETURNED TO HIS PRE-INJECTION DEGREE OF HYPERNASAL SPEECH RESONANCE. THE PATIENT'S PARENTS WERE STRONGLY IN FAVOR OF REPEATING INJECTION TO AVOID LARGER SURGICAL INTERVENTIONS. HYALURONIC ACID WAS AGAIN INJECTED FIVE MONTHS AFTER THE FIRST INJECTION. THE PATIENT TOLERATED THE REPEAT INJECTION WITHOUT EVENT AND HAD COMPLETE RESOLUTION OF AUDIBLE NASAL AIR EMISSION DURING SPEECH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    85153 HYALURONIC ACID HYALURONIC ACID MOZ FIDIA FARMACEUTICI S.P.A.

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR Other