BEUDAMED
    FDA Adverse Event Death Summary report: N

    VOLBELLA WITH LIDOCAINE

    MDR report key: 9512989 · Received December 23, 2019

    Report

    Report Number
    3005113652-2019-00925
    Event Type
    Death
    Date Received
    December 23, 2019
    Date of Event
    November 8, 2019
    Report Date
    February 27, 2020
    Manufacturer
    ALLERGAN (PRINGY)
    Product Code
    LMH
    PMA / PMN Number
    P110033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN COMPLETED. NO DEVIATIONS OR NON-CONFORMANCES NOTED.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTS PATIENT INJECTION WITH JUVÉDERM¿ VOLIFT¿ WITH LIDOCAINE AND 0.7 CC JUVÉDERM® VOLBELLA¿ WITH LIDOCAINE IN THE LIPS AND PUPPET LINES. ICE PROVIDED POST-TREATMENT. 10 DAYS LATER, PATIENT DEVELOPED A FEVER (40 ºC) AND ODYNOPHAGIA AND TOOK TYLENOL® (ACETAMINOPHEN). EVENT PROGRESSED WITH EPIDERMAL DETACHMENT CHARACTERISTIC OF TOXIC EPIDERMAL NECROLYSIS. SYMPTOM LOCATION NOTED AS "OCULAR, ORAL, VAGINAL MUCOSA-94% COMPROMISE OF BODY SURFACE" [AS REPORTED]. INJECTING PHYSICIAN SUGGESTED THAT THE PATIENT'S SYMPTOMS WERE COMPATIBLE WITH STEVEN JOHNSON´S SYNDROME AND REQUESTED HOSPITALIZATION. PATIENT PRESENTED CLINICAL IMBALANCE AND WAS HOSPITALIZED IN THE INTENSIVE CARE UNIT. INFLIXIMAB, GAMAGLOBULINE AND PENTOXIFILIN IV PROVIDED AS TREATMENT. PATIENT REMAINED IN PHARMACOLOGICAL COMA AND RESPIRATORY MECHANICAL ASSISTANCE (RMA). BIOPSY AND IMMUNOPATHOLOGY COMPLETED. ALL REQUESTED SEROLOGIES WERE NEGATIVE. 3 WEEKS LATER, PATIENT DIED DUE TO HEMODYNAMIC DECOMPENSATION. AN AUTOPSY WAS PERFORMED THE FOLLOWING DAY. THIS IS THE SAME EVENT AND THE SAME PATIENT REPORTED UNDER MDR ID# 3005113652-2019-00926 (ALLERGAN COMPLAINT# (B)(4)). THIS MDR IS BEING SUBMITTED FOR THE SECOND SUSPECT PRODUCT, JUVÉDERM® VOLBELLA¿ WITH LIDOCAINE.

    Additional Manufacturer Narrative · 1

    FURTHER INFORMATION REGARDING EVENT, PRODUCT, OR PATIENT DETAILS HAS BEEN REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THE EVENT IS A PHYSIOLOGICAL COMPLICATION AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THIS EVENT. A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN INITIATED. IF ANY NEW, CHANGED OR CORRECTED INFORMATION IS NOTED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTS PATIENT INJECTION WITH JUVÉDERM¿ VOLIFT¿ WITH LIDOCAINE AND 0.7 CC JUVÉDERM® VOLBELLA¿ WITH LIDOCAINE IN THE LIPS AND PUPPET LINES. ICE PROVIDED POST-TREATMENT. 10 DAYS LATER, PATIENT DEVELOPED A FEVER (40 ºC) AND ODYNOPHAGIA AND TOOK TYLENOL® (ACETAMINOPHEN). EVENT PROGRESSED WITH EPIDERMAL DETACHMENT CHARACTERISTIC OF TOXIC EPIDERMAL NECROLYSIS. SYMPTOM LOCATION NOTED AS "OCULAR, ORAL, VAGINAL MUCOSA-94% COMPROMISE OF BODY SURFACE" [AS REPORTED]. INJECTING PHYSICIAN SUGGESTED THAT THE PATIENT'S SYMPTOMS WERE COMPATIBLE WITH STEVEN JOHNSON´S SYNDROME AND REQUESTED HOSPITALIZATION. PATIENT PRESENTED CLINICAL IMBALANCE AND WAS HOSPITALIZED IN THE INTENSIVE CARE UNIT. INFLIXIMAB, GAMAGLOBULINE AND PENTOXIFILIN IV PROVIDED AS TREATMENT. PATIENT REMAINED IN PHARMACOLOGICAL COMA AND RESPIRATORY MECHANICAL ASSISTANCE (RMA). BIOPSY AND IMMUNOPATHOLOGY COMPLETED. ALL REQUESTED SEROLOGIES WERE NEGATIVE. 3 WEEKS LATER, PATIENT DIED DUE TO HEMODYNAMIC DECOMPENSATION. AN AUTOPSY WAS PERFORMED THE FOLLOWING DAY. THIS IS THE SAME EVENT AND THE SAME PATIENT REPORTED UNDER MDR ID# 3005113652-2019-00926 (ALLERGAN COMPLAINT# (B)(4)). THIS MDR IS BEING SUBMITTED FOR THE SECOND SUSPECT PRODUCT, JUVÉDERM® VOLBELLA¿ WITH LIDOCAINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1308234 VOLBELLA WITH LIDOCAINE IMPLANT, DERMAL, FOR AESTHETIC USE LMH ALLERGAN (PRINGY) V15LA70697

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Death| H JUVEDERM® VOLIFT¿ WITH LIDOCAINE