BEUDAMED
    FDA Adverse Event Other Summary report: N

    RESTYLANE INJECTABLE GEL

    MDR report key: 1515821 · Received October 23, 2009

    Report

    Report Number
    2032896-2009-00025
    Event Type
    Other
    Date Received
    October 23, 2009
    Date of Event
    September 12, 2009
    Report Date
    October 23, 2009
    Manufacturer
    Q-MED AB
    Product Code
    LMH
    PMA / PMN Number
    P040024 P020
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PHYSICIAN CONSIDERED THE EVENTS HARD TO BELIEVE, BUT STATED THAT ANYTHING WAS POSSIBLE. THE LOT NUMBER AND EXPIRATION DATE WERE 9725 AND 05/2011, RESPECTIVELY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Description of Event or Problem · 1

    ON 10/16/2009, A SPONTANEOUS REPORT WAS RECEIVED FROM A PHYSICIAN REGARDING A (B)(6) FEMALE, WHO RECEIVED AN INJECTION OF RESTYLANE (CROSS-LINKED HYALURONIC ACID DERMAL FILLER). MEDICAL HISTORY INCLUDED CHRONIC EPSTEIN-BARR VIRUS, MITRAL VALVE PROLAPSE, IRRITABLE BOWEL SYNDROME (IBS), CHRONIC BACK PAIN, PREVIOUS INJECTION OF BOTOX (BOTULINUM TOXIN TYPE A) WITHOUT SIDE EFFECTS, PREVIOUS INJECTION OF RESTYLANE ON AN UNSPECIFIED DATE IN (B)(6) 2009, RESULTING IN A GOOD OUTCOME WITHOUT SIDE EFFECTS AND NO PREVIOUS INJECTION OF PERLANE (CROSS-LINKED HYALURONIC ACID DERMAL FILLER). CONCOMITANT MEDICATIONS INCLUDED ZANTAC (RANITIDINE HYDROCHLORIDE), XANAX (ALPRAZOLAM), TYLENOL WITH CODEINE (ACETAMINOPHEN AND CODEINE) AND RHINOCORT (BUDESONIDE) NASAL SPRAY. THE PATIENT RECEIVED A 0.2 CC INJECTION OF RESTYLANE ON (B)(6) 2009 TO THE MARIONETTE LINES, INJECTED UPON WITHDRAWAL. NO PRE-PROCEDURE MEDICATIONS WERE USED AND NO ADDITIONAL PROCEDURES WERE PERFORMED AT THE TIME OF IMPLANTATION. ON (B)(6) 2009, 48 HOURS AFTER THE INJECTION, THE PATIENT STARTED TO COMPLAIN OF PAIN AT THE SITE OF INJECTION, WHICH TRAVELED FROM THE CORNER OF HER MOUTH, ALONG HER JAW LINE, TO HER EAR. THE PATIENT ALSO DEVELOPED WEAKNESS ON THE LEFT SIDE OF HER FACE. THE PATIENT CONTACTED THE INJECTING PHYSICIAN, WHO RECOMMENDED SHE BE EVALUATED IN THE EMERGENCY ROOM. THE INJECTING PHYSICIAN BELIEVED THAT THE PATIENT COULD BE EXPERIENCING A STROKE. THE PATIENT PRESENTED TO THE EMERGENCY ROOM AND WAS KEPT OVERNIGHT. THE PATIENT UNDERWENT A COMPUTED TOMOGRAPHY (CAT) SCAN, WHICH WAS NEGATIVE FOR STROKE, AND MULTIPLE UNSPECIFIED TESTS (RESULTS UNKNOWN). THE PATIENT WAS DIAGNOSED WITH BELL'S PALSY ON THE LEFT SIDE OF HER FACE. TREATMENT INCLUDED A COURSE OF STEROIDS AND PHYSICAL THERAPY. THE PATIENT WAS RELEASED FROM THE EMERGENCY ROOM SEVERAL HOURS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTYLANE INJECTABLE GEL INJECTABLE DERMAL FILLER LMH Q-MED AB NA 9725

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR RHINOCORT (BUDESONIDE) NASAL SPRAY| ZANTAC (RANITIDINE HYDROCHLORIDE)| XANAX (ALPRAZOLAM)| TYLENOL WITH CODEINE (ACETAMINOPHEN AND CODEINE)