BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTYLANE L, RESTYLANE LIDOCAINE

    MDR report key: 3489360 · Received November 15, 2013

    Report

    Report Number
    2032896-2013-00577
    Event Type
    Injury
    Date Received
    November 15, 2013
    Report Date
    October 28, 2013
    Manufacturer
    MEDICIS AESTHETICS, INC.
    Product Code
    LMH
    PMA / PMN Number
    P040024
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PHARMACOVIGILANCE COMMENT: PB (B)(4) 2013, THE EVENT CELLULITIS WAS ASSESSED AS SERIOUS AND POSSIBLY RELATED.

    Description of Event or Problem · 1

    THIS SPONTANEOUS CASE WAS REC'D ON (B)(4) 2013, FROM A NON HCP AND CONCERNED ABOUT A PATIENT OF UNKNOWN AGE AND GENDER. THE PATIENTS' MEDICAL HISTORY AND CONCOMITANT MEDICATIONS WERE NOT REPORTED. ON UNKNOWN DATES, THE PATIENT STARTED TREATMENT WITH RESTYLANE L (CROSS LINKED HYALURONIC ACID) FOR UNKNOWN INDICATION. IT WAS REPORTED THAT ON (B)(6) 2013 THE CONSUMER HAD SUBMITTED PRODUCT COMPLAINTS FOR 5 DIFFERENT RESTYLANE-L PRODUCTS. ALL 5 PRODUCTS RETURNS HAD THE SAME LOT NUMBER, HOWEVER, THE NUMBERS WERE NOT REPORTED. AMONGST THE FIVE PRODUCT COMPLAINTS, THERE WAS A PATIENT WHO HAD EXPERIENCED CELLULITIS. THE OUTCOME OF THE EVENT WAS UNKNOWN. THE REPORTER DID NOT PROVIDE A CAUSALITY ASSESSMENT. FOR REFERENCE PURPOSES ONLY, THIS CASE HAS ALSO BEEN ASSIGNED THE FOLLOWING TRACKING NUMBERS: (B)(4) (MEDCOMM SOLUTIONS ON BEHALF OF (B)(4)). THIS CASE IS LINKED TO (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    593474 RESTYLANE L, RESTYLANE LIDOCAINE NA LMH MEDICIS AESTHETICS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other