BEUDAMED
    FDA Adverse Event Other Summary report: N

    HYALURONIC ACID (BRAND NAME NOT REPORTED)

    MDR report key: 1702440 · Received May 27, 2010

    Report

    Report Number
    2032896-2010-00018
    Event Type
    Other
    Date Received
    May 27, 2010
    Date of Event
    January 1, 2008
    Report Date
    May 27, 2010
    Manufacturer
    UNK
    Product Code
    LMH
    PMA / PMN Number
    P040024
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE HEALTHCARE PROFESSIONAL ALSO REPORTED INFO REGARDING ONE ADDITIONAL INJECTION OF HYALURONIC ACID DERMAL FILLER IN THIS PT ((B)(4)). ADDITIONAL PMA/510(K): P020023.

    Description of Event or Problem · 1

    ON (B)(6) 2010, A LITERATURE ARTICLE WAS RETRIEVED DESCRIBING A FEMALE (THE PT'S AGE AT THE TIME OF THE EVENT ONSET WAS NOT REPORTED; THE PT WAS (B)(6) AT THE TIME OF THE REPORT) WHO RECEIVED AN INJECTION OF HYALURONIC ACID (HA) DERMAL FILLER (BRAND NAME NOT REPORTED). PARK, HJ, JUNG, KH, KIM, SY, LEE, JH, JEONG, JY, KIM, JH. HYALURONIC ACID PULMONARY EMBOLISM: A CRITICAL CONSEQUENCE OF AN ILLEGAL COSMETIC VAGINAL PROCEDURE. THORAX 2010;65 (4): 360-361. MEDICAL HISTORY WAS NOT REPORTED. THE PT DID NOT SMOKE AND DENIED A HISTORY OF DRUG ABUSE. THE PT'S SKIN TYPE WAS NOT REPORTED. CONCOMITANT MEDICATIONS WERE NOT REPORTED. THE PT RECEIVED AN INJECTION OF HYALURONIC ACID (HA) DERMAL FILLER ON AN UNSPECIFIED DATE IN 2008 FOR G-SPOT AMPLIFICATION. ON AN UNSPECIFIED DATE IN 2008, THE PT VISITED THE HOSPITAL FOR MILD DYSPNEA WITH COUGH. THE PT HAD A PLAIN CHEST X-RAY THAT SHOWED PATCHY INFILTRATIONS IN BOTH LOWER LUNG FIELDS. THE PT DID NOT INFORM THE PHYSICIANS AT THE HOSPITAL OF THE PROCEDURE SHE HAD RECEIVED. THE PT'S SYMPTOMS AND RADIOGRAPHIC ABNORMALITIES IMPROVED SPONTANEOUSLY. NO ADDITIONAL INFO WAS PROVIDED. THE LOT NUMBER AND EXPIRATION DATE WERE NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HYALURONIC ACID (BRAND NAME NOT REPORTED) INJECTABLE DERMAL FILLER LMH UNK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Hospitalization NOT REPORTED