BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTYLANE, RESTYLANE

    MDR report key: 3644353 · Received February 14, 2014

    Report

    Report Number
    2032896-2014-00078
    Event Type
    Injury
    Date Received
    February 14, 2014
    Date of Event
    June 25, 2013
    Report Date
    January 14, 2014
    Manufacturer
    Q-MED
    Product Code
    LMH
    PMA / PMN Number
    P020023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PMA/510(K): P020023/P040024. PHARMACOVIGILANCE COMMENT: (B)(4) 2014: IMPLANT SITE OEDEMA, IMPLANT SITE PAIN, SKIN BURNING SENSATION, IMPLANT SITE INFLAMMATION, IMPLANT SITE PARAESTHESIA, IMPLANT SITE INDURATION, HYPERSENSITIVITY ASSESSED AS SERIOUS AND POSSIBLY RELATED.

    Description of Event or Problem · 1

    THIS IS A VERBATIM REPORT AS RECEIVED BY (B)(4) FROM Q-MED: THIS SPONTANEOUS CASE WAS RECEIVED FROM A PHYSICIAN AND CONCERNED A (B)(6) YEAR OLD FEMALE PATIENT. THE PATIENT'S MEDICAL HISTORY INCLUDED LIPOATROPHY IN THE FACE. NO INFORMATION REGARDING ALLERGIES. CONCOMITANT MEDICATIONS WERE NOT REPORTED. ON (B)(6) 2013, THE PATIENT WAS INJECTED WITH RESTYLANE (CROSS LINKED HYALURONIC ACID) 12ML INJECTION SUBCUTANEOUS ON THE FOREHEAD, NOSE, CHIN, AROUND THE NOSE AND MOUTH FOR AN UNKNOWN INDICATION. THE BATCH NUMBER USED WAS NOT REPORTED. THE PATIENT WAS AGAIN TREATED WITH RESTYLANE, ON (B)(6) 2013, 1ML ON THE CHIN AND 0.2 ML UNDER THE EYE AREA. IT WAS REPORTED THE PATIENT ALSO USED BOTOX INJECTIONS FOR LIPOLYSIS ON THE FACE. ON (B)(6) 2013, THE PATIENT EXPERIENCED EDEMA, PAIN AND BURNING SENSATION ON HER FOREHEAD. AS TREATMENT SHE WAS GIVEN HYALASE, STEROIDS, AND ORAL ANTIBIOTICS ON (B)(6) 2013. THE PHYSICIAN CHECKED THE SYMPTOMS ON (B)(6) 2013 AND IT WAS NOTED THAT THE EVENTS OF PAIN AND EDEMA UNDER THE RIGHT EYE HAD RECOVERED. THE PATIENT HAD EDEMA AND PAIN UNDER THE LEFT EYE'S AREA FROM (B)(6) 2013, THE PATIENT EXPERIENCED EDEMA AND PAIN UNDER BOTH OF HER EYES. AS TREATMENT THE PATIENT AGAIN RECEIVED HYALASE, STEROID, AND ORAL ANTIBIOTIC THERAPY. ON (B)(6) 2013, THE PATIENT WAS DIAGNOSED WITH INFLAMMATION ON THE CHIN. THE PATIENT ALSO HAD PARAESTHESIA AND HARDNESS ON THE CHIN FROM (B)(6) 2013. THE PATIENT WAS DIAGNOSED WITH AN ALLERGIC REACTION AND RECEIVED ORAL ANTIHISTAMINE, HYLASE, STEROID, AND VITAMIN TREATMENT. THE PATIENTS TREATMENT FOR THE ADVERSE EVENTS ARE AS FOLLOWED: HYALURONIDASE, INJECTION 10500 IU, FOREHEAD (ON (B)(6) 2013), DEXAMETHASONE, IM 5 MG (ON (B)(6) 2013), AUGMENTIN TAB (POTASSIUM CLAVULANATE 125 MG, AMOXICILLIN 250 MG) THREE TIMES A DAY (START (B)(6)2013, STOP (B)(6) 2013; START AND STOP (B)(6) 2013), HYALURONIDASE, INJECTION 12000 IU, UNDER EYES AREA, AROUND MOUTH (ON (B)(6) 2013), CIPROFLOXACIN, ORAL (THREE TIMES A DAY (B)(6) 2013). HYALURONIDASE, INJECTION 9000 IU, BOTH CHEEKS, CHIN (ON (B)(6) 2013). CEPHRADINE, IVS IG (ON (B)(6) 2013), HYALURONIDASE, INJECTION 10500IU (ON (B)(6), 2013), HYALURONIDASE, INJECTION 12000IU (ON (B)(6) 2013), DEXAMETHSONE, IM 5MG (ON (B)(6) 2013), DEXAMETHASONE, IV 5MG (ON (B)(6) 2013), PREDNISOLONE, ORAL 5MG (THREE TIMES A DAY ON (B)(6) 2013), PREDNISOLONE, ORAL 10MG (TWICE A DAY ON (B)(6) 2013), PREDNISOLONE, ORAL 5MG (TWICE A DAY ON (B)(6) 2013), IBUPROFEN THREE TIMES A DAY, CHLORPHENIRAMINE MALEATE TWICE A DAY (START (B)(6) 2013), HYALURONIDASE, INJECTION 6000 IU (ON (B)(6) 2013), HYALURONIDASE, INJECTION 3000 IU (ON (B)(6) 2013), MEGA VITAMIN IV, DEXAMETHASONE 5 MG IV (ON (B)(6) 2013), PREDNISOLONE, ORAL 5MG (TWICE A DAY ON (B)(6) 2013 TO ONGOING). IT WAS REPORTED PHOTO DOCUMENTATION IS AVAILABLE . THE SYMPTOMS ARE REPORTED TO BE RECURRENT AND NOT RECOVERED/ NOT RESOLVED. THE REPORTER'S CAUSALITY IS CONDITIONAL/UNCLASSIFIED. THE COMPANY'S CAUSALITY FOR THE CASE IS POSSIBLE. COMPANY COMMENT: A CASUAL RELATION BETWEEN THE EVENTS AND THE TREATMENT CANNOT BE EXCLUDED. COMPANY COMMENT: 12 ML OF GEL IN THE FACE AREA IS A RATHER LARGE VOLUME. GENERAL ADVICE FOR PATIENT MANAGEMENT HAS BEEN SENT TO THE REPORTER. THE ADVERSE EVENT IS NOT UNEXPECTED. LOT NUMBER WAS NOT REPORTED AND TRENDING ON BATCH CANNOT BE PERFORMED. FOR REFERENCE PURPOSES ONLY, THIS CASE HAS ALSO BEEN ASSIGNED THE FOLLOWING TRACKING NUMBERS: (B)(4). THIS CASE WAS RECEIVED BY Q-MED AND WAS FORWARDED TO (B)(4) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    97793 RESTYLANE, RESTYLANE INJECTABLE DERMAL FILLER LMH Q-MED

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Other BOTOX (BOTULINUM TOXIN TYPE A) (INJECTION)