BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTYLANE, RESTYLANE

    MDR report key: 3649344 · Received February 21, 2014

    Report

    Report Number
    2032896-2014-00099
    Event Type
    Injury
    Date Received
    February 21, 2014
    Report Date
    February 12, 2013
    Manufacturer
    Q-MED
    Product Code
    LMH
    PMA / PMN Number
    P020023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PMA/510(K): P020023/P040024. PHARMACOVIGILANCE COMMENT: (B)(4) 2014: IMPLANT SITE PAIN, IMPLANT SITE ERYTHEMA, IMPLANT SITE DISCHARGE, IMPLANT SITE INFLAMMATION, IMPLANT SITE NECROSIS ASSESSED AS SERIOUS AND POSSIBLY RELATED.

    Description of Event or Problem · 1

    THIS IS A VERBATIM REPORT AS RECEIVED BY VALEANT FROM (B)(6): THE CASE IS A LITERATURE REPORT (SUNG HM, SUH IS, LEE HB, TAK KS, MOON KM, JUNG MS. ARCHIVES OF PLASTIC SURGERY, 2012; 39: 51-54, CASE REPORT OF ADIPOSE - DERIVED STEM CELL THERAPY FOR NASAL SKIN NECROSIS AFTER FILLER INJECTION) WHICH REFERS TO A (B)(6)-YEAR-OLD-FEMALE ((B)(4)). A (B)(6) YEAR-OLD FEMALE RECEIVED A RESTYLANE INJECTION ON HER FOREHEAD, GLABELLA, AND NOSE BY A NON-MEDICAL PROFESSIONAL. THE DAY AFTER HER INJECTION, SHE EXPERIENCED TENDERNESS AND REDNESS ON THE INJECTION AREA, SO SHE WAS TREATED WITH INTRAVENOUS ANTI-BIOTICS AND HYDROCOLLOID DRESSING. ON THE FIFTH DAY AFTER INJECTION, HER WOUND EXHIBITED PUS-LIKE DISCHARGE, SEVERE INFLAMMATION, AND 3 X 3 CM SKIN NECROSIS OVER HER NASAL TIP, LATERAL WALL, AND DORSUM. FOLLOWING HER HOSPITAL ADMISSION, SHE UNDERWENT INTRAVENOUS ANTI-BIOTICS AND DEBRIDEMENT OF NECROTIC TISSUE. ON THE THIRD DAY OF ADMISSION, SHE RECEIVED ADIPOSE-DERIVED STEM CELL THERAPY ON HER NOSE. HER WOUND WAS COMPLETELY RE-EPITHELIZED 10 DAYS AFTER INJECTION, AND 6 MONTHS OF FOLLOW-UP, A LINEAR SCAR REMAINS ONLY IN THE NOSE TIP AREA WITHOUT SCAR CONTRACTURE DEFORMITY. COMPANY COMMENT: A CAUSAL RELATION BETWEEN THE EVENTS AND THE TREATMENT IS NOT UNLIKELY. INTRAVASCULAR INJECTION / ISCHEMIA / NECROSIS IS INCLUDED IN THE INSTRUCTIONS FOR USE FOR RESTYLANE IN THE SECTIONS WARNINGS, PRECAUTION AND ADVERSE EVENT. SPECIAL CAUTION SHOULD BE EXERCISED WHEN TREATING AREAS WITH LIMITED COLLATERAL CIRCULATION. PROGRESS AND FOLLOW-UP: A LINEAR SCAR REMAINS ONLY IN THE NOSE TIP AREA WITHOUT SCAR CONTRACTURE AND DEFORMITY DURING 6 MONTHS FOLLOW-UP AFTER ADIPOSE-DERIVED STEM CELL THERAPY. FOR REFERENCE PURPOSES ONLY, THE FOLLOWING TRACKING NUMBER HAS BEEN ASSIGNED:(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    108865 RESTYLANE, RESTYLANE INJECTABLE DERMAL FILLER LMH Q-MED

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Hospitalization