BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCULPTRA AESTHETIC

    MDR report key: 7785062 · Received August 15, 2018

    Report

    Report Number
    9710154-2018-00051
    Event Type
    Injury
    Date Received
    August 15, 2018
    Report Date
    November 15, 2018
    Manufacturer
    GALDERMA Q-MED
    Product Code
    LMH
    PMA / PMN Number
    P030050/S2
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    CAPA COMMENT: THE INFORMATION IN THIS SINGLE CASE DOES NOT SUGGEST INVOLVEMENT OF A NONCONFORMING PRODUCT OR QUALITY PROBLEM AND WILL NOT INITIATE A CORRECTIVE OR PREVENTIVE ACTION. MANUFACTURER NARRATIVE: NO POTENTIAL QUALITY ISSUES HAVE BEEN IDENTIFIED IN THE MANUFACTURING PROCESS OF THE SPECIFIED BATCH. THE BATCH IS MANUFACTURED AND RELEASED ACCORDING TO GALDERMA QUALITY MANAGEMENT SYSTEM. PHARMACOVIGILANCE COMMENT: A CAUSAL RELATIONSHIP BETWEEN THE TREATMENTS AND THE EXPECTED EVENTS OF BLURRED VISION AND HEADACHE COULD NOT BE RULED OUT. SERIOUS CRITERIA FOR BLURRED VISION INCLUDED POSSIBLE DISABILITY, WHILE HEADACHE WAS CONSIDERED NON-SERIOUS. POTENTIAL ETIOLOGIES FOR THE EVENTS INCLUDE POSSIBLE OPHTHALMIC VASCULAR COMPROMISE DUE TO VASCULAR COMPRESSION, TRAUMA OR EMBOLIC OCCLUSION. CORRECTIVE TREATMENTS FOR THE EVENTS INCLUDE METHYLPREDNISOLONE, IBUPROFEN AND CEFALEXIN ANTIBIOTIC THERAPY SUGGESTING THAT INFLAMMATION AND INFECTION WERE CONSIDERED AS POSSIBLE CAUSES FOR THE EVENTS. POTENTIAL CONTRIBUTORY FACTORS INCLUDE THE MEDICAL HISTORY OF SWELLING ASSOCIATED WITH AN UNKNOWN FILLER IMPLANT, AND CONCOMITANT INJECTION OF ABOBOTULINUMTOXINA, SINCE OCCURRENCE WITHIN A THREE DAY PERIOD AFTER TREATMENT IS CONSISTENT WITH THE TIME TO ONSET FOR TOXIN EFFECTS OF DISTANT SPREAD. THE CASE MET THE SERIOUSNESS CRITERIA FOR EXPEDITED REPORTING TO THE REGULATORY AUTHORITIES. FOLLOW-UP INFORMATION WILL BE REQUESTED. EXEMPTION: EXEMPTION NUMBER: E2015005. GALDERMA LABORATORIES, L.P. (IMPORTER) IS SUBMITTING THE REPORT ON BEHALF OF Q-MED AB (MANUFACTURER).

    Additional Manufacturer Narrative · 0

    CAPA COMMENT: THE INFORMATION IN THIS SINGLE CASE DOES NOT SUGGEST INVOLVEMENT OF A NONCONFORMING PRODUCT OR QUALITY PROBLEM AND WILL NOT INITIATE A CORRECTIVE OR PREVENTIVE ACTION. MANUFACTURER NARRATIVE: NO POTENTIAL QUALITY ISSUES HAVE BEEN IDENTIFIED IN THE MANUFACTURING PROCESS OF THE SPECIFIED BATCH. THE BATCH IS MANUFACTURED AND RELEASED ACCORDING TO GALDERMA QUALITY MANAGEMENT SYSTEM. PHARMACOVIGILANCE COMMENT: A CAUSAL RELATIONSHIP BETWEEN THE TREATMENTS AND THE EXPECTED EVENTS OF BLURRED VISION AND HEADACHE COULD NOT BE RULED OUT. SERIOUS CRITERIA FOR BLURRED VISION INCLUDED POSSIBLE DISABILITY, WHILE HEADACHE WAS CONSIDERED NON-SERIOUS. POTENTIAL ETIOLOGIES FOR THE EVENTS INCLUDE POSSIBLE OPHTHALMIC VASCULAR COMPROMISE DUE TO VASCULAR COMPRESSION, TRAUMA OR EMBOLIC OCCLUSION. CORRECTIVE TREATMENTS FOR THE EVENTS INCLUDE METHYLPREDNISOLONE, IBUPROFEN AND CEFALEXIN ANTIBIOTIC THERAPY SUGGESTING THAT INFLAMMATION AND INFECTION WERE CONSIDERED AS POSSIBLE CAUSES FOR THE EVENTS. POTENTIAL CONTRIBUTORY FACTORS INCLUDE THE MEDICAL HISTORY OF SWELLING ASSOCIATED WITH AN UNKNOWN FILLER IMPLANT, AND CONCOMITANT INJECTION OF ABOBOTULINUMTOXINA, SINCE OCCURRENCE WITHIN A THREE DAY PERIOD AFTER TREATMENT IS CONSISTENT WITH THE TIME TO ONSET FOR TOXIN EFFECTS OF DISTANT SPREAD. THE CASE MET THE SERIOUSNESS CRITERIA FOR EXPEDITED REPORTING TO THE REGULATORY AUTHORITIES. FOLLOW-UP INFORMATION WILL BE REQUESTED. EXEMPTION: EXEMPTION NUMBER E2015005 GALDERMA LABORATORIES, L.P. (IMPORTER) IS SUBMITTING THE REPORT ON BEHALF OF Q-MED AB (MANUFACTURER).

    Description of Event or Problem · 0

    CASE REFERENCE NUMBER: (B)(4) IS A SPONTANEOUS REPORT SENT ON (B)(6) 2018 BY A OTHER HEALTH PROFESSIONAL WHICH REFERS TO A FEMALE PATIENT AGED 59 YEARS. SHE HAD A FITZPATRICK SKIN TYPE III-IV. THE PATIENT'S MEDICAL HISTORY INCLUDED SWELLING FOLLOWING PAST FILLER INJECTION, AND ALLERGIES WERE NOT REPORTED. CONCOMITANT TREATMENT WAS LIDOCAINE. THE PATIENT ALSO RECEIVED TREATMENT WITH SCULPTRA, RESTYLANE AND JUVEDERM IN THE PAST ON UNREPORTED DATES. ON (B)(6) 2018, THE PATIENT RECEIVED TREATMENT WITH 1.5 ML SCULPTRA AESTHETIC (LOT A7124) TO JAW, TEMPLE, CHEEK, CHIN WITH UNKNOWN NEEDLE AND TECHNIQUE. ON (B)(6) 2018, THE PATIENT RECEIVED TREATMENT WITH 1 ML RESTYLANE-L (LOT: 16072) TO LIPS, CHIN WITH UNKNOWN NEEDLE AND TECHNIQUE. ON (B)(6) 2018, THE PATIENT RECEIVED TREATMENT WITH AN UNSPECIFIED AMOUNT OF DYSPORT TO UNSPECIFIED AREAS. AT AN UNKNOWN TIME LATER, THE PATIENT EXPERIENCED A MILD BILATERAL HEADACHE(HEADACHE) AND BLURRED VISION(VISION BLURRED). TREATMENT FOR THE ADVERSE EVENT INCLUDED KEFLEX [CEFALEXIN], IBUPROFEN [IBUPROFEN], AND MEDROL [METHYLPREDNISOLONE]. OUTCOME AT THE TIME OF THE REPORT: HEADACHE WAS NOT RECOVERED/NOT RESOLVED. BLURRED VISION WAS NOT RECOVERED/NOT RESOLVED.

    Description of Event or Problem · 0

    CASE (B)(4) IS A SPONTANEOUS REPORT SENT ON 06-AUG-2018 BY A OTHER HEALTH PROFESSIONAL WHICH REFERS TO A FEMALE PATIENT (B)(6). THE PATIENT'S MEDICAL HISTORY INCLUDED SWELLING FOLLOWING PAST FILLER INJECTION, AND ALLERGIES WERE NOT REPORTED. CONCOMITANT TREATMENTS WERE NOT REPORTED. THE PATIENT ALSO RECEIVED TREATMENT WITH SCULPTRA, RESTYLANE AND JUVEDERM IN THE PAST ON UNREPORTED DATES. ON (B)(6) 2018, THE PATIENT RECEIVED TREATMENT WITH 1.5 ML SCULPTRA AESTHETIC (LOT A7124) TO JAW, TEMPLE, CHEEK, CHIN WITH UNKNOWN NEEDLE AND TECHNIQUE. ON (B)(6) 2018, THE PATIENT RECEIVED TREATMENT WITH 1 ML RESTYLANE-L (LOT 16072) TO LIPS, CHIN WITH UNKNOWN NEEDLE AND TECHNIQUE. ON (B)(6) 2018, THE PATIENT RECEIVED TREATMENT WITH AN UNSPECIFIED AMOUNT OF DYSPORT TO UNSPECIFIED AREAS. AT AN UNKNOWN TIME LATER, THE PATIENT EXPERIENCED HEADACHE(HEADACHE) AND BLURRED VISION(VISION BLURRED). TREATMENT FOR THE ADVERSE EVENT INCLUDED KEFLEX [CEFALEXIN], IBUPROFEN [IBUPROFEN], AND MEDROL [METHYLPREDNISOLONE]. OUTCOME AT THE TIME OF THE REPORT: HEADACHE WAS NOT RECOVERED/NOT RESOLVED. BLURRED VISION WAS NOT RECOVERED/NOT RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    628102 SCULPTRA AESTHETIC IMPLANT, DERMAL, FOR AESTHETIC USE LMH GALDERMA Q-MED A7124

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Disability DYSPORT| DYSPORT| LIDOCAINE| DYSPORT