BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNSPECIFIED HA FILLER

    MDR report key: 7104756 · Received December 11, 2017

    Report

    Report Number
    1000118068-2017-00102
    Event Type
    Injury
    Date Received
    December 11, 2017
    Report Date
    December 19, 2017
    Manufacturer
    GALDERMA QMED
    Product Code
    LMH
    PMA / PMN Number
    P040024
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ENGINEERING EVALUATION: THE REPORTED EVENT IS A KNOWN RISK ASSOCIATED WITH FILLER TREATMENT. NO CORRECTIVE OR PREVENTIVE ACTION WILL BE INITIATED. MANUFACTURER NARRATIVE: LOT NUMBER WAS NOT REPORTED. THE SUSPECT PRODUCT IS AN UNSPECIFIED HYALURONIC ACID FILLER. PHARMACOVIGILANCE COMMENT: THE SERIOUS EVENT OF IMPLANT SITE ABSCESS WAS CONSIDERED EXPECTED AND POSSIBLY RELATED TO THE TREATMENT WITH UNSPECIFIED HA FILLER. THE SERIOUS CRITERIA INCLUDED THE NEED FOR THE MEDICAL INTERVENTIONS OF INCISION AND DRAINAGE AND SYSTEMIC ANTIBIOTICS. CONTRIBUTORY FACTORS INCLUDE THE THREAD FACE LIFT PROCEDURE. THE CASE MEETS THE CRITERIA FOR EXPEDITED REPORTING TO THE REGULATORY AUTHORITIES. EXEMPTION: (B)(4) IS SUBMITTING THIS REPORT ON BEHALF OF Q-MED AB. EXEMPTION NUMBER E2015005.

    Description of Event or Problem · 0

    CASE REFERENCE NUMBER (B)(4) IS A LITERATURE REPORT SENT ON 16-NOV-2017. DURING LOCAL LITERATURE SEARCH, AN ARTICLE WAS FOUND IN THE GERMAN JOURNAL "AKTUELLE DERMATOLOGIE" 2017: 43: 399-407, CONTAINING THREE VIGILANCE CASES. THIS IS THE FIRST OF THREE REPORTS, SEE DE17011289 (SERIOUS) AND DE17011313 (NON-SERIOUS) FOR THE OTHER CASES FOR REFERENCE. BARSCH ET AL.: AESTHETIC FILLER INJECTIONS AND THE MANAGEMENT OF SIDE EFFECTS. AKT DERMATOL 2017: 43: 399-407. THE CASE INVOLVED A (B)(6) MALE PATIENT WHO UNDERWENT A THREAD FACELIFT WITH FILLER TREATMENT WITH AN UNSPECIFIED HYALURONIC ACID FILLER. THE TREATMENT WAS PERFORMED BY AN ALTERNATIVE PRACTITIONER. AROUND 3 WEEKS AFTER THE TREATMENT, MULTIPLE ABSCESSES OCCURRED IN THE PATIENT'S FACE, AND HE PRESENTED TO THE REPORTER. SONOGRAPHIC IMAGING OF THE NASOLABIAL FOLDS WITH ABSCESSES REVEALED AN ECHO-POOR MASS WITH DORSAL SOUND AMPLIFICATION, WITH THE DIFFERENTIAL DIAGNOSIS OF A HYALURONIC ACID FILLER WITH ABSCESS. THE THREAD WAS VISIBLE AS AN ECHO-RICH REFLEX. ABSCESSES WERE INCISED AND DRAINED, AND SYSTEMIC ANTIBIOTIC TREATMENT WAS PERFORMED WITH CLINDAMYCIN 600 MG, THRICE PER DAY FOR THREE WEEKS. 4 WEEKS LATER, THE PATIENT WAS RECOVERING FROM THE ADVERSE EVENTS.

    Additional Manufacturer Narrative · 1

    ENGINEERING EVALUATION: THE REPORTED EVENT IS A KNOWN RISK ASSOCIATED WITH FILLER TREATMENT. NO CORRECTIVE OR PREVENTIVE ACTION WILL BE INITIATED. MANUFACTURER NARRATIVE: LOT NUMBER WAS NOT REPORTED. THE SUSPECT PRODUCT IS AN UNSPECIFIED HYALURONIC ACID FILLER. PHARMACOVIGILANCE COMMENT: THE SERIOUS EVENT OF IMPLANT SITE ABSCESS WAS CONSIDERED EXPECTED AND POSSIBLY RELATED TO THE TREATMENT WITH UNSPECIFIED HA FILLER. THE SERIOUS CRITERIA INCLUDED THE NEED FOR THE MEDICAL INTERVENTIONS OF INCISION AND DRAINAGE AND SYSTEMIC ANTIBIOTICS. CONTRIBUTORY FACTORS INCLUDE THE THREAD FACE LIFT PROCEDURE. THE CASE MEETS THE CRITERIA FOR EXPEDITED REPORTING TO THE REGULATORY AUTHORITIES. EXEMPTION: (B)(4). EXEMPTION NUMBER E2015005. (B)(4).

    Description of Event or Problem · 1

    CASE REFERENCE NUMBER (B)(4) IS A LITERATURE REPORT SENT ON 16-NOV-2017. DURING LOCAL LITERATURE SEARCH, AN ARTICLE WAS FOUND IN THE GERMAN JOURNAL "AKTUELLE DERMATOLOGIE" 2017: 43: 399-407, CONTAINING THREE VIGILANCE CASES. THIS IS THE FIRST OF THREE REPORTS, SEE (B)(4) (SERIOUS) AND (B)(4) (NON-SERIOUS) FOR THE OTHER CASES FOR REFERENCE. BARSCH ET AL.: AESTHETIC FILLER INJECTIONS AND THE MANAGEMENT OF SIDE EFFECTS. AKT DERMATOL 2017: 43: 399-407. THE CASE INVOLVED A (B)(6) YEAR-OLD MALE PATIENT WHO UNDERWENT A THREAD FACELIFT WITH FILLER TREATMENT WITH AN UNSPECIFIED HYALURONIC ACID FILLER. THE TREATMENT WAS PERFORMED BY AN ALTERNATIVE PRACTITIONER. AROUND 3 WEEKS AFTER THE TREATMENT, MULTIPLE ABSCESSES OCCURRED IN THE PATIENT'S FACE, AND HE PRESENTED TO THE REPORTER. SONOGRAPHIC IMAGING OF THE NASOLABIAL FOLDS WITH ABSCESSES REVEALED AN ECHO-POOR MASS WITH DORSAL SOUND AMPLIFICATION, WITH THE DIFFERENTIAL DIAGNOSIS OF A HYALURONIC ACID FILLER WITH ABSCESS. THE THREAD WAS VISIBLE AS AN ECHO-RICH REFLEX. ABSCESSES WERE INCISED AND DRAINED, AND SYSTEMIC ANTIBIOTIC TREATMENT WAS PERFORMED WITH CLINDAMYCIN 600 MG, THRICE PER DAY FOR THREE WEEKS. 4 WEEKS LATER, THE PATIENT WAS RECOVERING FROM THE ADVERSE EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    884209 UNSPECIFIED HA FILLER IMPLANT, DERMAL, FOR AESTHETIC USE LMH GALDERMA QMED

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention