BEUDAMED
    FDA Adverse Event Other Summary report: N

    RESTYLANE INJECTABLE GEL

    MDR report key: 1258155 · Received December 5, 2008

    Report

    Report Number
    9710154-2008-00023
    Event Type
    Other
    Date Received
    December 5, 2008
    Date of Event
    June 1, 2006
    Report Date
    December 3, 2008
    Manufacturer
    Q-MED
    Product Code
    LMH
    PMA / PMN Number
    P020023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL PMA/510(K): P040024.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED VIA CUSTOMER SERVICE FROM A (B) (6) FEMALE WHO RECEIVED RESTYLANE INJECTABLE GEL (INJECTABLE DERMAL FILLER) INJECTIONS INTO THE UPPER LIP ON (B) (6) 2006 "TO ADD FULLNESS TO UPPER LIP." ANESTHESIA AND ADDITIONAL PROCEDURES WERE NOT REPORTED. SIGNIFICANT MEDICAL HISTORY INCLUDED PREVIOUS RESTYLANE INJECTIONS ON AN UNSPECIFIED DATE IN (B) (6) 2005. CONCOMITANT MEDICATIONS INCLUDED MULTIVITAMIN AND TRINESTA (BIRTH CONTROL PILL). ACCORDING TO THE REPORTER, SHE NOTICED A "GOOD SIZE BUMP" (IMPLANT SITE MASS) ABOVE THE RIGHT SIDE OF HER UPPER LIP ON (B) (6) 2006. SHE DESCRIBED THE BUMP AS PALPABLE BUT NOT HARD. ON (B) (6) 2008, THE PATIENT WAS EVALUATED BY HER PHYSICIAN WHO INDICATED THAT THE BUMP WAS SCAR TISSUE BUILD UP. (IMPLANT SITE SCAR) AND NOTED NO RESIDUAL FROM RESTYLANE. SHE REPORTED THAT HER PHYSICIAN "TRIED TO SQUEEZE OUT THE BUMP BUT COULD NOT." AS OF THE DATE THIS REPORT WAS RECEIVED, THE EVENTS HAVE REMAINED UNRESOLVED. THE RESTYLANE LOT NUMBER AND EXPIRATION DATE WERE NOT REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR MULTIVITAMIN| TRINESTA