BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JUVEDERM ULTRA XC TSK US

    MDR report key: 3893852 · Received June 12, 2014

    Report

    Report Number
    3005113652-2014-00248
    Event Type
    Injury
    Date Received
    June 12, 2014
    Date of Event
    May 17, 2014
    Report Date
    May 20, 2014
    Manufacturer
    ALLERGAN
    Product Code
    LMH
    PMA / PMN Number
    P050047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENTS OF "SWELLING", "DISCOMFORT", "LOOKS LIKE WATER POCKETS", FULL AND HARD" ARE PHYSIOLOGICAL COMPLICATIONS AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THIS EVENT. DEVICE LABELING: POSTMARKET SURVEILLANCE. SERIOUS ADVERSE EVENTS HAVE INFREQUENTLY BEEN REPORTED FOR JEVEDERM ULTRA (REPORTED WITH A FREQUENCY OF 5 OR MORE). THE MOST COMMONLY REPORTED SERIOUS ADVERSE EVENTS WERE EDEMA, ERYTHEMA, ECCHYMOSIS, PRURITUS, INDURATION, AND PAIN. THE ONSET OF EDEMA GENERALLY VARIED FROM IMMEDIATE TO 2 WEEKSPOST-INJECTION. THE TREATMENT PRESCRIBED INCLUDED AMICA, NSAIDS, ANTIHISTAMINES, ANTIBIOTICS, STEROIDS, AND HYALURONIDASE. IN MOST CASES, EDEMA RESOLVED WITHIN A DAY TO A MONTH. THE ONSET OF ECCHYMOSIS GENERALLY VARIED FROM IMMEDIATE TO 5 DAYS POST-INJECTION. THE TREATMENT PRESCRIBED INCLUDED AMICA, NSAIDS, ANTIHISTAMINES, ANTIBIOTICS, STEROIDS, AND HYALURONIDASE. IN MOST CASES, ECCHYMOSIS RESOLVED WITHIN 1 DAY TO 4 WEEKS. THE ONSET OF INDURATION GENERALLY VARIED FROM 1 DAY TO 2 MONTHS POST-INJECTION. THE TREATMENT PRESCRIBED INCLUDED ANTIHISTAMINES, ANTIBIOTICS, STEROIDS, AND HYALURONIDASE. IN MOST CASES, INDURATION RESOLVED WITHIN 1 WEEK. THE ONSET OF PAIN GENERALLY VARIED FROM IMMEDIATE TO 8 DAYS POST-INJECTION. THE TREATMENT PRESCRIBED INCLUDED NSAIDS, ANTIHISTAMINES, ANTIBIOTICS, STEROIDS, AND HYALURONIDASE. IN MOST CASES, PAIN RESOLVED WITHIN 1 TO 6 WEEKS.

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTED THAT 3 DAYS AFTER INJECTION WITH JUVEDERM ULTRA XC IN THE NASOLABIAL FOLDS, THE PATIENT EXPERIENCED "SWELLING UNDER THE EYES AND DOWN THE CHEEKS, DISCOMFORT WHEN OPENING THE MOUTH, LOOKS LIKE WATER POCKETS UNDER THE EYES AND LEFT CHEEK IS FULL AND HARD." THE PATIENT HAD ALSO BEEN INJECTED WITH CONCOMITANT JUVEDERM VOLUMA XC IN THE "BILATERAL MALAR AREAS" AS WELL AS BOTOX IN THE "FOREHEAD". THREE DAYS AFTER THE ONSET OF SYMPTOMS THE PATIENT SELF TREATED WITH "BENADRYL AND ICE PACKS". THREE DAYS LATER "DURICEL" WAS PRESCRIBED BY THE INJECTING PHYSICIAN "IN CASE OF DEEPENED INFECTION." HOWEVER, THE INJECTING PHYSICIAN DOES NOT BELIEVE THAT AN INJECTION OCCURRED. THE TREATMENTS WERE CONSIDERED "PROPHYLACTIC" AND TO ENSURE "NO PERMANENT DAMAGE WOULD OCCUR." THE PATIENT CAME BACK TO THE OFFICE THE FOLLOWING DAY AND THE INJECTING PHYSICIAN PERFORMED AN ULTRASOUND ON THE LEFT CHEEK. THE RESULTS SHOWED A HEMATOMA IN THE SUBMALAR AND SUBZYGOMATIC AREA. THE INJECTOR ATTEMPTED TO WITHDRAW FLUID FROM THE HEMATOMA BUT WAS UNABLE TO WITHDRAW FLUID FROM IT. THE PATIENT'S EYES WERE NOTED TO BE SWOLLEN, BUT MORE ON THE LEFT SIDE THAN THE RIGHT. THE PHYSICIAN DIDN'T PRESCRIBE OR GIVE ANY FURTHER TREATMENT ANY THEY DECIDED TO LET THE PATIENT CONTINUE TAKING THE ANTIBIOTICS AND LET THE SKIN HEAL ON ITS OWN. THE SYMPTOMS HAVE NOT YET BEEN REPORTED AS RESOLVED. THIS IS THE SAME EVENT AND THE SAME PATIENT REPORTED UNDER MDR ID # 3005113652-2014-00257 (ALLERGAN COMPLAINT # (B)(4)). THIS IS THE FIRST MDR SUBMITTED FOR THE FIRST SUSPECTED PRODUCT. JUVEDERM ULTRA XC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    348896 JUVEDERM ULTRA XC TSK US LMH ALLERGAN NA H24LA30285

    Patients

    Seq Age Sex Outcome Treatment
    1 "MULTI VITAMIN"| JUVEDERM VOLUMA XC IN THE "BILATERAL MALAR AREAS| BOTOX IN THE "FOREHEAD"