BEUDAMED
    FDA Adverse Event Other Summary report: N

    RESTYLANE INJECTABLE GEL

    MDR report key: 1244346 · Received November 26, 2008

    Report

    Report Number
    9710154-2008-00022
    Event Type
    Other
    Date Received
    November 26, 2008
    Date of Event
    October 18, 2008
    Report Date
    November 24, 2008
    Manufacturer
    Q-MED AB
    Product Code
    LMH
    PMA / PMN Number
    P020023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL PMA/510K # - P040024.

    Description of Event or Problem · 1

    THIS SPONTANEOUS REPORT OF NONSERIOUS, UNLABELED EVENT (EYE DISCHARGE) MEETS THE CRITERIA OF AN EXPEDITED 10-DAY REPORT. INFO WAS RECEIVED FROM A FEMALE PT (AGE UNSPECIFIED) WHO RECEIVED RESTYLANE INJECTIONS INTO AN UNSPECIFIED SITE ON (B)(6) 2008. MINIMAL INFO WAS RECEIVED AT THE TIME OF REPORTING. THEREFORE, THE FOLLOWING INFO WAS NOT INCLUDED IN THIS REPORT: ANESTHESIA, ADDITIONAL PROCEDURE, MEDICAL HISTORY , CONCOMITANT MEDICATIONS, TREATMENT MEDICATION AND EVENT OUTCOME. ACCORDING TO THE PT, SHE DEVELOPED EYE DISCHARGE (EYE DISCHARGE) "8 DAYS LATER POST RESTYLANE INJECTION" ((B)(6) 2008). ADDITIONALLY, SHE REPORTED THAT HER EYES "WENT BACK TO THE WAY THEY WERE" (DEVICE INEFFECTIVE, MEDICAL DEVICE IMPLANTATION). AS OF THE DATE OF THIS REPORT, THE EVENT OF EYE DISCHARGE WAS CONSIDERED 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 AB NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Other