BEUDAMED
    FDA Adverse Event Other Summary report: N

    RESTYLANE INJECTABLE GEL

    MDR report key: 1697361 · Received May 21, 2010

    Report

    Report Number
    2032896-2010-00016
    Event Type
    Other
    Date Received
    May 21, 2010
    Date of Event
    February 9, 2010
    Report Date
    May 20, 2010
    Manufacturer
    Q-MED AB
    Product Code
    LMH
    PMA / PMN Number
    P040024
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    MEDICAL HISTORY INCLUDED MULTIPLE PRIOR INJECTABLE PROCEDURES INCLUDING SCULPTRA (POLY-L-LACTIC ACID) AND RESTYLANE WITH GOOD OUTCOME. THE PATIENT'S SKIN TYPE WAS REPORTED AS "TYPE II." CONCOMITANT MEDICATIONS WERE REPORTED AS UNKNOWN. THE PATIENT RECEIVED A I CC INJECTION OF RESTYLANE TO THE RIGHT TEAR TROUGH. PRE-PROCEDURE MEDICATION INCLUDED LMX5 (LIDOCAINE 5%) TOPICAL. NO ADDITIONAL PROCEDURES WERE PERFORMED AT THE TIME OF IMPLANTATION. THE PHYSICIAN REPORTED THE SYRINGE FRACTURED AT THE THREADS DURING THE INJECTION. THE INJECTING PHYSICIAN REPORTED HE DID NOT KNOW THE FINAL SEQUELAE OTHER THAN THE PATIENT EXPERIENCED SEVERE BRUISING AND NEAR COMPLETE LOSS OF HER LOWER EYELID LASHES. THE PHYSICIAN ASSESSED THE SEVERITY OF THE EVENTS AS SEVERE. ASSOCIATED PRODUCT COMPLAINT (B)(4). ADDITIONAL PMA/510(K) # P020023.

    Description of Event or Problem · 1

    ON (B)(6) 2010, A SPONTANEOUS REPORT BY A PHYSICIAN WAS RECEIVED FROM THE PHYSICIAN'S WIFE REGARDING A (B)(6) FEMALE WHO RECEIVED AN INJECTION OF RESTYLANE (CROSS-LINKED HYALURONIC ACID DERMAL FILLER). ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2010 FROM THE PHYSICIAN. BASED ON THE INFORMATION RECEIVED, THE CASE WAS REASSESSED AS NON-SERIOUS, UNEXPECTED. ON AN UNSPECIFIED DATE THE SYRINGE EXPLODED WHILE THE PATIENT WAS BEING INJECTED. THE PATIENT EXPERIENCED BRUISING. IT WAS REPORTED ONE SYRINGE WAS USED, APPROXIMATE QUANTITY REMAINING IN SYRINGE WAS 1/4 LEFT, AND SIZE OF NEEDLE AND COLOR OF HUB: 32 GAUGE AND BROWN. THE LOT NUMBER AND EXPIRATION DATE WERE 9890-1 AND 09/2011, RESPECTIVELY. COMPANY COMMENT: PRODUCT QUALITY ISSUE IS NOT AN ADVERSE EVENT. ON (B)(6) 2010, ADDITIONAL INFORMATION WAS RECEIVED FROM THE PHYSICIAN. THE PATIENT RECEIVED A 1 CC INJECTION OF RESTYLANE ON (B)(6) 2010 TO THE RIGHT TEAR TROUGH. PRE-PROCEDURE MEDICATION INCLUDED LMX5 (LIDOCAINE 5%) TOPICAL. NO ADDITIONAL PROCEDURES WERE PERFORMED AT THE TIME OF IMPLANTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTYLANE INJECTABLE GEL INJECTABLE DERMAL FILLER LMH Q-MED AB NA 9890-1

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR