BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERLANE L, PERLANE

    MDR report key: 3096406 · Received April 26, 2013

    Report

    Report Number
    2032896-2013-00022
    Event Type
    Injury
    Date Received
    April 26, 2013
    Date of Event
    June 21, 2012
    Report Date
    September 20, 2012
    Manufacturer
    Q-MED
    Product Code
    LMH
    PMA / PMN Number
    P040024
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PHARMACOVIGILANCE COMMENT: (B)(6) ON (B)(6) 2013. THE EVENT DEEP TISSUE INFECTION ASSESSED AS SERIOUS, EXPECTED AND POSSIBLY RELATED.

    Description of Event or Problem · 1

    CASE REFERENCE NUMBER (B)(4) IS A SPONTANEOUS CASE REPORT SENT BY A OTHER HEALTH PROFESSIONAL WHICH REFERS TO A FEMALE AGED (B)(6). THE PATIENT'S PAST MEDICAL HISTORY INCLUDED RENAL PARENCHYMA STONE REMOVAL, PARTIAL NEPHRECTOMY, CRP INCREASED, PYELONEPHRITIS, DRUG HYPERSENSITIVITY AND RENAL TRAUMA IN CHILDHOOD. NO PREVIOUS TREATMENTS WITH THE FILLERS. ON (B)(6) 2012, THE PATIENT WAS TREATED WITH RESTYLANE LIDOCAINE (LOT 11555, EXP DATE ON 07/2013) WITH 29G (THE RED ONE IN THE PACKET) WITH FAN AND LINEAR TECHNIQUE ON HAPPYCORNER/ORAL SOMMISSURES + LINES LATERAL FROM THE MOUTH 0.5 ML EACH SIDE. RESTYLANE PERLANE LIDOCAINE (LOT 11614, EXP DATE ON 08/2013) WITH 29G (RED) WITH FAN AND LINER TECHNIQUE ON NASOLABIAL FOLDS + ORAL COMMISSURES 0.5 ML EACH SIDE. PATIENT SEEN AT CLINIC ON 3RD DAY AFTER COSMETIC TREATMENT (RESTYLANE + PERLANE) OBVIOUS SIGNS OF INFLAMMATION IN TREATED AREA - POSSIBLE INFECTION. PATIENT TREATED WITH HERACILLIN 5 MG, 1TBL X 3 TIMES A DAY. NO EFFECT. SIX DAYS AFTER COSMETIC TREATMENT REFERRED TO THE (B)(6) HOSPITAL CLINIC. THE ADVERSE EVENT IS: DEEP TISSUE INFECTION IN TREATED AREAS (IMPLANT SITE INFECTION) WHICH BEGAN ON (B)(6) 2012. THE REACTION WAS DEEMED SERIOUS BY THE REPORTER BECAUSE IT REQUIRED INTERVENTION. PATIENT SEEN AT HOSPITAL ON (B)(6) 2012; AFEBRIL WITH REDNESS, SWELLING AND TENDERNESS AROUND MOUTH. PATIENT ADMITTED TO IV ANTIBIOTICS TREATMENT BETWEEN ON (B)(6) 2012. PATIENT TREATED FOLLOWING: ON (B)(6) 2012 WITH ANTIBIOTICS DICILLIN 1 G X 3 DAILY (I.V.) AND BENZYLPENICILLIN 1.2 G X 3 DAILY (I.V.). ON (B)(6) 2012 WITH AZITHROMYCIN 500 MG X 1 DAILY TABLET AND MOXAFLOXACIN 100 MG X 1 DAILY IV ON (B)(6) 2012 WITH AMYLOX 400 MG X 1 DAILY AND AZITHROMYCIN 500 MG X 1 DAILY TABLET. ON (B)(6) 2012 PATIENT CONTACTED THE HOSPITAL AGAIN FOR RECURRENT INFECTION SYMPTOMS DESPITE THE PER ORAL ANTIBIOTICS. ON (B)(6) 2012 1 WEEK IV. TREATMENT THE SWELLING RESOLVED AND ONLY SMALL ERYTHEMATOUS AREA ON LEFT NASOLABIAL FOLD. THE SETTING FOR THE EVENT WAS A MULTIPLE AREAS. THE REACTION WAS DEEMED SERIOUS BY THE REPORTER BECAUSE IT REQUIRED HOSPITALIZATION AND INTERVENTION. THE OUTCOME FOR DEEP TISSUE INFECTION IN TREATED AREAS IS RECOVERING/RESOLVING. REMAINING ONLY MINOR ERYTHEMATOUS AREA ON LEFT NASOLABIAL FOLD AREA. THIS CASE IS CROSS REFERENCED WITH CASE (B)(4) (SAME PATIENT).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    181511 PERLANE L, PERLANE INJECTABLE DERMAL FILLER LMH Q-MED 11614

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization| R