BEUDAMED
    FDA Adverse Event Other Summary report: N

    RESTYLANE INJECTABLE GEL

    MDR report key: 1613185 · Received February 5, 2010

    Report

    Report Number
    2032896-2010-00002
    Event Type
    Other
    Date Received
    February 5, 2010
    Date of Event
    January 1, 2008
    Report Date
    February 4, 2010
    Manufacturer
    Q-MED AB
    Product Code
    LMH
    PMA / PMN Number
    P040024
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL PMA/510(K) P020023. THE LOT NUMBER AND EXPIRATION DATE WERE REPORTED AS UNKNOWN. COMPANY COMMENT: COMPANY CAUSALITY CANNOT BE ASSESSED AT THE TIME OF THIS REPORT DUE TO NO FURTHER INFO PROVIDED.

    Description of Event or Problem · 1

    ON (B)(6) 2010, A SPONTANEOUS REPORT IN THE FORM OF A MEDWATCH WAS RECEIVED VIA (B)(4)FROM AN ATTORNEY REGARDING A (B)(6) FEMALE WHO RECEIVED AN INJECTION OF RESTYLANE (CROSS-LINKED HYALURONIC ACID DERMAL FILLER). THE PT HAD NO RELEVANT MEDICAL HISTORY OR PRE-EXISTING CONDITIONS. THE PT'S SKIN TYPE WAS NOT REPORTED. CONCOMITANT MEDICATIONS WERE NOT REPORTED. THE PT RECEIVED A ".2.5 CC" INJECTION OF RESTYLANE ON (B)(6) 2008 TO 6 UNSPECIFIED SITES INTRADERMALLY FOR DEEP WRINKLES. THE PT RECEIVED ANOTHER ".3 CC" INJECTION OF RESTYLANE ON (B)(6) 2008 TO 5 UNSPECIFIED SITES INTRADERMALLY FOR DEEP WRINKLES. PRE-PROCEDURE MEDICATIONS AND ADDITIONAL PROCEDURES PERFORMED AT THE TIME OF IMPLANTATION WERE NOT REPORTED. ON AN UNSPECIFIED DATE IN 2008 OR 2009, THE PT DEVELOPED DERMATOMYOSITIS AFTER RECEIVING RESTYLANE INJECTIONS. A DELAY IN DIAGNOSIS RESULTED IN SEVERE HEART MUSCLE DAMAGE. ON (B)(6) 2009, THE PT REQUIRED A HEART TRANSPLANT. NO ADDITIONAL INFO WAS PROVIDED.

    Additional Manufacturer Narrative · 2

    PMA NUMBER: P020023. COMPANY COMMENT: COMPANY CAUSALITY CANNOT BE ASSESSED AT THE TIME OF THIS REPORT DUE TO NO FURTHER INFO PROVIDED.

    Description of Event or Problem · 2

    ON (B)(6) 2010, A SPONTANEOUS REPORT IN THE FORM OF A MEDWATCH WAS RECEIVED VIA (B)(4) FROM AN ATTORNEY REGARDING A (B)(6) FEMALE WHO RECEIVED AN INJECTION OF RESTYLANE (CROSS-LINKED HYALURONIC ACID DERMAL FILLER). THE PT HAD NO RELEVANT MEDICAL HISTORY OR PRE-EXISTING CONDITIONS. THE PT'S SKIN TYPE WAS NOT REPORTED. CONCOMITANT MEDICATIONS WERE NOT REPORTED. THE PT RECEIVED A "2.5 CC" INJECTION OF RESTYLANE ON (B)(6) 2008 TO 6 UNSPECIFIED SITES INTRADERMALLY FOR DEEP WRINKLES. THE PT RECEIVED ANOTHER ".3 CC" INJECTION OF RESTYLANE ON (B)(6) 2008 TO 5 UNSPECIFIED SITES INTRADERMALLY FOR DEEP WRINKLES. PRE-PROCEDURE MEDICATIONS AND ADDITIONAL PROCEDURES PERFORMED AT THE TIME OF IMPLANTATION WERE NOT REPORTED. ON AN UNSPECIFIED DATE IN 2008 OR 2009, THE PT DEVELOPED DERMATOMYOSITIS AFTER RECEIVING RESTYLANE INJECTIONS. A DELAY IN DIAGNOSIS RESULTED IN SEVERE HEART MUSCLE DAMAGE. ON (B)(6) 2009, THE PT REQUIRED A HEART TRANSPLANT. NO ADDITIONAL INFO WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention NOT REPORTED.
    2 59 YR NOT REPORTED