BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JUVEDERM ULTRA PLUS XC TSK US

    MDR report key: 5527453 · Received March 25, 2016

    Report

    Report Number
    3005113652-2016-00192
    Event Type
    Injury
    Date Received
    March 25, 2016
    Date of Event
    February 21, 2013
    Report Date
    February 26, 2013
    Manufacturer
    ALLERGAN (PRINGY)
    Product Code
    LMH
    PMA / PMN Number
    P050047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY RECORD SUMMARY: THE DOCUMENTARY RESEARCH IN THE BATCH FILE SHOWS THAT NO ELEMENT COULD EXPLAIN THESE REACTIONS: ALL THE MANUFACTURING STEPS AND ALL THE PHYSICOCHEMICAL AND MICROBIOLOGICAL RESULTS (ENDOTOXINS, BIOBURDEN) ARE REGISTERED AS CONFORMING TO THE SPECIFICATIONS. THE STERILIZATION CYCLE IS REGISTERED AS CONFORMING.

    Additional Manufacturer Narrative · 1

    MEDWATCH SENT TO FDA ON 03/25/2016. (B)(4).. FURTHER INFORMATION FROM THE REPORTER REGARDING EVENT, PRODUCT, OR PATIENT DETAILS HAS BEEN REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THE EVENTS OF REDNESS, SWELLING, PAIN AT INJECTION SITE, AND WHITE PUSTULES THAT LOOK LIKE AN INFECTION ARE PHYSIOLOGICAL COMPLICATIONS AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THESE EVENTS. DEVICE LABELING ADDRESSES THE REPORTED EVENTS AS FOLLOWS: WARNINGS: ¿INJECTION PROCEDURE REACTIONS CONSIST MAINLY OF SHORT-TERM INFLAMMATORY SYMPTOMS STARTING EARLY AFTER TREATMENT AND LASTING = 7 DAYS¿ DURATION.¿ ADVERSE EVENTS: ¿THE MOST COMMON INJECTION-SITE RESPONSES FOR JUVÉDERM® ULTRA PLUS XC WERE REDNESS, SWELLING, TENDERNESS, FIRMNESS, LUMPS/BUMPS, DISCOLORATION, AND BRUISING.¿ POST-MARKET SURVEILLANCE: ¿THE FOLLOWING ADVERSE EVENTS WERE RECEIVED FROM POSTMARKET SURVEILLANCE FOR JUVÉDERM® ULTRA (WITHOUT LIDOCAINE), WHICH WERE NOT OBSERVED IN THE CLINICAL TRIALS; THIS INCLUDES REPORTS RECEIVED GLOBALLY FROM ALL SOURCES INCLUDING SCIENTIFIC JOURNALS AND VOLUNTARY REPORTS. ADVERSE EVENTS WITH A FREQUENCY OF 5 OR MORE EVENTS ARE LISTED IN ORDER OF PREVALENCE: INFLAMMATION AT THE INJECTION SITE, ALLERGIC REACTION, BLISTER, INFECTION AT THE INJECTION SITE, SKIN RASH, BLEEDING AT THE INJECTION SITE, NECROSIS AT THE INJECTION SITE, ABSCESS AT THE INJECTION SITE, AND HEADACHE.¿ ¿INFLAMMATION AT THE INJECTION SITE, MOSTLY A NONSERIOUS EVENT, HAS BEEN REPORTED IN ASSOCIATION WITH EDEMA, ERYTHEMA, ECCHYMOSIS, PRURITUS, INDURATION, PAIN, NODULE, ABSCESS, AND INFECTION. TIME TO ONSET RANGED FROM 1 DAY TO 4 MONTHS POST JUVÉDERM® ULTRA PLUS INJECTION, AND OUTCOME RANGED FROM RESOLVED TO ONGOING AT LAST CONTACT. INTERVENTIONS PRESCRIBED BY THE PHYSICIANS INCLUDED TOPICAL STEROIDAL CREAM, ORAL STEROIDS, AND ANTIBIOTICS. ADDITIONAL TREATMENT NOTED WAS A NEEDLE ASPIRATION FOR DRAINAGE OF AN ABSCESS.¿ ¿NECROSIS HAS MOSTLY BEEN REPORTED AFTER TREATMENT IN THE FOREHEAD OR GLABELLAR REGION AND ASSOCIATED WITH A VASCULAR EVENT, SKIN DISCOLORATION, BLISTER, PAIN, SCAR, OR INFECTION. TIME TO ONSET RANGED FROM 1 TO 3 DAYS POST JUVÉDERM® ULTRA PLUS INJECTION, AND OUTCOME RANGED FROM RESOLVED WITH LITTLE TO NO RESIDUAL EFFECTS TO SCARRING AT THE TREATMENT SITE. INTERVENTIONS PRESCRIBED BY THE PHYSICIANS INCLUDED TOPICAL STEROIDAL CREAM, ANTIBACTERIAL OINTMENT OR CREAM, NITROPASTE, ORAL STEROIDS, ASPIRIN, AND ORAL OR INJECTABLE ANTIBIOTICS. ADDITIONAL TREATMENTS NOTED WERE INJECTABLE HYALURONIDASE, LASER RESURFACING, TISSUE DEBRIDEMENT, AND SURGICAL SCAR REVISION.¿ ¿SERIOUS ADVERSE EVENTS HAVE INFREQUENTLY BEEN REPORTED FOR JUVÉDERM® ULTRA PLUS (REPORTED WITH A FREQUENCY OF 5 OR MORE). THE MOST COMMONLY REPORTED SERIOUS ADVERSE EVENTS WERE EDEMA, ERYTHEMA, ECCHYMOSIS, AND PAIN.¿ ¿THE ONSET OF EDEMA, ERYTHEMA, AND PAIN GENERALLY VARIED FROM IMMEDIATE TO 2 MONTHS POST-INJECTION. THE TREATMENT PRESCRIBED INCLUDED NSAIDS, ANTIHISTAMINES, ANTIBIOTICS, STEROIDS, AND HYALURONIDASE. IN MOST CASES, THE REPORTED EVENTS RESOLVED WITHIN A FEW DAYS TO 5 WEEKS.¿ ¿ADDITIONALLY THERE HAVE BEEN REPORTS OF NODULES, INFECTION, AND INFLAMMATION.¿ ¿THE ONSET OF INFECTION GENERALLY VARIED FROM IMMEDIATE TO 1 MONTH POST-INJECTION. THE TREATMENT PRESCRIBED INCLUDED ANTIBIOTICS, PAIN KILLERS, AND ANTIBACTERIAL DRUGS.¿

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTED AFTER INJECTION IN THE NASOLABIAL FOLDS WITH JUVÉDERM® ULTRA PLUS XC THE PATIENT DEVELOPED "REDNESS, SWELLING, PAIN AT INJECTION SITE, AND WHITE PUSTULES THAT LOOK LIKE AN INFECTION." PATIENT WAS TREATED WITH HYALURONIDASE, KEFLEX, VALTREX AND ACYCLOVIR. ALL PERFORMED CULTURES HAVE YIELDED NEGATIVE RESULTS. SYMPTOMS RESOLVED APPROXIMATELY THREE MONTHS AFTER SYMPTOM ONSET.

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTED AFTER INJECTION IN THE NASOLABIAL FOLDS WITH JUVEDERM ULTRA PLUS XC THE PATIENT DEVELOPED "REDNESS, SWELLING, PAIN AT INJECTION SITE, AND WHITE PUSTULES THAT LOOK LIKE AN INFECTION." PATIENT WAS TREATED WITH HYALURONIDASE, KEFLEX, VALTREX AND ACYCLOVIR. ALL PERFORMED CULTURES HAVE YIELDED NEGATIVE RESULTS. SYMPTOMS RESOLVED APPROXIMATELY THREE MONTHS AFTER SYMPTOM ONSET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    181350 JUVEDERM ULTRA PLUS XC TSK US IMPLANT, DERMAL, FOR AESTHETIC USE LMH ALLERGAN (PRINGY) H30LA20067

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention