BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTYLANE, RESTYLANE

    MDR report key: 3232260 · Received July 9, 2013

    Report

    Report Number
    2032896-2013-00238
    Event Type
    Injury
    Date Received
    July 9, 2013
    Report Date
    June 25, 2013
    Manufacturer
    Q-MED
    Product Code
    LMH
    PMA / PMN Number
    P020023/P040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PHARMACOVIGILANCE COMMENT: SEVERE REACTION TO LIPS ASSESSED AS NON SERIOUS AND POSSIBLY RELATED. PB (B)(6) 2013. SEVERE REACTION TO LIPS UPDATED TO LIP SWELLING AND ASSESSED AS SERIOUS AND POSSIBLY RELATED. ADD'L EVENTS OF NAUSEATED AFTER INJECTION, SWELLING OF FACE, (B)(6) INFECTION, MOUTH BLISTERING, INFECTION OF NOSE, RASH ASSESSED AS SERIOUS AND POSSIBLY RELATED.

    Description of Event or Problem · 1

    THIS IS A SPONTANEOUS REPORT AS RECEIVED BY (B)(4) FROM A CONSUMER ON (B)(6) 2013. ON AN UNK DATE, A FEMALE PT WAS PLACED ON THERAPY WITH RESTYLANE (CROSS LINKED HYALURONIC ACID DERMAL FILLER); DOSE AND SPECIFIED INDICATION WERE UNK. ON AN UNK DATE, THE PT INQUIRED ABOUT SIDE EFFECTS WITH RESTYLANE (CROSS LINKED HYALURONIC ACID DERMAL FILLER) AND WHETHER THE PHYSICIAN MAY HAVE HAD A "BLACK MARKET" PRODUCT. SHE STATED SHE EXPERIENCED "SEVERE REACTION TO LIPS" AND WAS TREATED WITH ANTIBIOTICS AND "STEROID SHOTS FOR 2 MONTHS." THE PT HUNG-UP AND HENCE, NO FURTHER INFO IS AVAILABLE AT THIS TIME. THE PTS MEDICAL HISTORY INCLUDED COSMETIC PROCEDURES. CONCOMITANT MEDICATIONS, IF ANY, WERE UNK. NO FURTHER INFO IS AVAILABLE AT THIS TIME. ADDENDUM-1 ((B)(4) 2013): NEWLY RECEIVED DATE: MEDICAL INFO RECEIVED NEW INFO FROM THE PT ON (B)(6) 2013. THE PT REPORTED THAT SHE FELT NAUSEATED THE EVENING AFTER HER INJECTION. WHEN SHE WOKE UP THE NEXT MORNING, HER FACE AND LIPS WERE SWOLLEN. THE PHYSICIAN TREATED HER WITH AMOXICILLIN AND A "STEROID INJECTION IN HER HIP." THE PT DESCRIBED THE INSIDE OF HER MOUTH WAS "PEPPERED WITH BLISTERS EVERYWHERE." THE PHYSICIAN THEN ADDED VALTREX. APPROX 1-2 WEEKS LATER, THE PT RETURNED TO THE PHYSICIAN BECAUSE THERE WAS AN INFECTION IN HER NOSE. THE PHYSICIAN CHANGED THE ANTIBIOTIC TO BACTRIM AND CONTINUED THE VALTREX. THE PT REPORTED THAT THE NOSE INFECTION WENT AWAY. ON (B)(6) 2013, THE PT RETURNED TO THE PHYSICIAN FOR SWELLING ON HER RIGHT CHEEK THAT "KEPT GROWING" AND INVOLVED THE "WHOLE RIGHT SIDE OF HER FACE." HER PHYSICIAN LANCED THE SITE AND SENT A SPECIMEN FOR EXAMINATION. THE RESULTS OF THE CULTURE WAS "HEAVY (B)(6)." HER ANTIBIOTICS WERE CHANGED TO BACTRIM PLUS TETRACYCLINE. THE SWELLING STARTED TO GO DOWN AND THE PRESCRIPTIONS WERE RENEWED ON (B)(6) 2013. AS OF (B)(6) 2013, THE PT REPORTED THAT SHE IMPROVED BUT STILL HAD A "LITTLE" BUMP ON HER CHEEK. ON (B)(6) 2013, THE PT CONSULTED WITH A DIFFERENT PHYSICIAN WHO SWABBED HER TO CHECK FOR (B)(6) AND WAS TOLD THAT IF SHE DID NOT HEAR BACK FROM HIM, THAT "THE TEST WAS OK." AS OF THE DATE OF THIS ADDENDUM REPORT, THE PT HAD NOT HEARD BACK FROM THE SECOND PHYSICIAN. THE PT REPORTED THAT ON (B)(6) 2013, SHE DEVELOPED A RASH UNDERNEATH HER LEFT BREAST WHICH SHE THINKS IS A YEAST INFECTION AS A RESULT OF HER ANTIBIOTIC USE. THE PT WOULD LIKE TO REPORT THAT SHE DID NOT SEE THE BOX OF RESTYLANE (CROSS LINKED HYALURONIC ACID DERMAL FILLER) THAT WAS USED ON HER. FOR REFERENCE PURPOSES ONLY, THIS CASE HAS ALSO BEEN ASSIGNED THE FOLLOWING TRACKING NUMBERS: (B)(4) (MEDCOMM SOLUTIONS ON BEHALF OF (B)(4)).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312237 RESTYLANE, RESTYLANE INJECTABLE DERMAL FILLER LMH Q-MED

    Patients

    Seq Age Sex Outcome Treatment
    1 Other