BEUDAMED
    FDA Adverse Event Other Summary report: N

    RESTYLANE INJECTABLE GEL

    MDR report key: 1195004 · Received October 10, 2008

    Report

    Report Number
    9710154-2008-00017
    Event Type
    Other
    Date Received
    October 10, 2008
    Date of Event
    August 1, 2008
    Report Date
    October 6, 2008
    Manufacturer
    Q-MED AB
    Product Code
    LMH
    PMA / PMN Number
    P020023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). ADDITIONAL PMA/510(K)#: P040024.

    Description of Event or Problem · 1

    THIS SPONTANEOUS REPORT OF A NON-SERIOUS, UNLABELED EVENT (CAPILLARY DISORDER) IS BEING SUBMITTED AS A 10-DAY REPORT. A NURSE PRACTIONER REPORTED A (B) (6) FEMALE PATIENT RECEIVED AN INJECTION OF RESTYLANE INJECTABLE GEL (INJECTABLE DERMAL FILLER) TO THE NASOLABIAL FOLDS AND LIPS ON (B) (6) 2008. ANESTHESIA IN THE FORM OF DENTAL BLOCK WAS USED PRE-PROCEDURE. MEDICAL HISTORY INCLUDED PREVIOUS RESTYLANE AND BOTOX WITHOUT DIFFICULTY. CONCOMITANT MEDICATIONS INCLUDED ESTROGEN. THE PATIENT REPORTED IN (B) (6) 2008 THAT SHE HAD BEEN NOTICING BROKEN CAPILLARIES (CAPILLARY DISORDER) IN THE NASOLABIAL FOLD AREA, MORE ON THE LEFT SIDE THAN RIGHT. TREATMENT INCLUDED INTENSE PULSE LIGHT (IPL) ON (B) (6) 2008 AND (B) (6) 2008. THE NURSE PRACTITIONER REPORTED THE TREATMENT HELPS THE EVENT, BUT IT DOES COME BACK AFTER A COUPLE OF WEEKS. THE NURSE PRACTITIONER'S OPINION OF CAUSALITY WAS RELATED TO THE PROCEDURE. THE NURSE PRACTITIONER STATED SHE WAS NOT SURE IF THE INJECTION TECHNIQUE OR THE PRODUCT CAUSED THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTYLANE INJECTABLE GEL INJECTABLE DERMAL FILLER LMH Q-MED AB NA 9152

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR ESTROGEN