BEUDAMED
    FDA Adverse Event Other Summary report: N

    RESTYLANE INJECTABLE GEL

    MDR report key: 1479956 · Received September 21, 2009

    Report

    Report Number
    2032896-2009-00023
    Event Type
    Other
    Date Received
    September 21, 2009
    Date of Event
    May 1, 2007
    Report Date
    September 18, 2009
    Manufacturer
    Q-MED AB
    Product Code
    LMH
    PMA / PMN Number
    P040024
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL PMA/510(K)# P020023. THE PHYSICIAN STATED HE DIDN'T KNOW EXACTLY WHAT CAUSED THE SCAR, BUT THAT THERE DID SEEM TO BE A CAUSAL RELATIONSHIP TO THE RESTYLANE IMPLANT. THE ONLY OTHER THING HE COULD THINK OF, WHICH WOULD HAVE BEEN SPECULATIVE, WAS THAT MAY BE A SMALL ARTERIOLE VESSEL WAS INFARCTED WHICH WOULD HAVE RESULTED IN SCARRING. HOWEVER, THERE WAS NO ULCERATION OF THE AREA, WHICH YOU WOULD EXPECT WITH AN INTERARTERIAL INJECTION.

    Description of Event or Problem · 1

    ON 09/11/2009, A SPONTANEOUS REPORT WAS RECEIVED FROM A PHYSICIAN REGARDING A FEMALE (AGE AT TIME OF THE EVENT IS UNK, AGE AT TIME OF REPORT WAS (B) (6)) WHO RECEIVED AN INJECTION OF RESTYLANE (CROSS-LINKED HYALURONIC ACID DERMAL FILLER). MEDICAL HISTORY INCLUDED NO KNOWN ALLERGIES ADN NO PREVIOUS USE OF ANY DERMAL FILLERS. THE PT WAS NOT TAKING ANY CONCOMITANT MEDICATIONS. THE PT RECEIVED A 1 ML INJECTION OF RESTYLANE ON (B) (6) 2007 TO THE NASOLABIAL FOLD AND UPPER AND LOWER LIPS; BOTH THE UPPER AND LOWER LIPS WERE INJECTED WITH VERY GOOD OVERALL RESULTS. PRE-PROCEDURE MEDICATIONS INCLUDED AN UNSPECIFIED LOCAL BLOCK. THE PT HAD NO ADDITIONAL PROCEDURES AT THE TIME OF IMPLANTATION. ON AN UNSPECIFIED DATE IN (B) (6) 2007, ABOUT 3 MONTHS POST-INJECTION, THE PT DEVELOPED A LESION ON THE LEFT MEDIAL LOWER LIP. THE LESION WAS 3 X 5 MM AT THE VERMILLION BORDER. THE LESION WAS CAUTERIZED AND BIOPSIED. THE BIOPSY SHOWED HYPERTROPHIC SCAR TISSUE; NO FOREIGN MATERIAL WAS FOUND IN THE BIOPSY. TREATMENT CONSISTED OF AN INJECTION OF CORTISONE. THE LESION WAS REMOVED AND THE PT HAD A SMALL SCAR THERE AT THE TIME OF THE REPORT. THE PHYSICIAN COMMENTED THAT THE SCAR WAS A UNIQUE ISOLATED PART OF A LARGER TREATMENT AREA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTYLANE INJECTABLE GEL INJECTABLE DERMAL FILLER LMH Q-MED AB NA 8036

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK