BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNSPECIFIED HA FILLER

    MDR report key: 7104754 · Received December 11, 2017

    Report

    Report Number
    1000118068-2017-00101
    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 EVENTS ARE EXPECTED WITH FILLER INJECTIONS. 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 EVENTS OF VASCULAR OCCLUSION, IMPLANT SITE NECROSIS, AND SCAR WERE CONSIDERED EXPECTED AND POSSIBLY RELATED TO THE TREATMENT WITH UNSPECIFIED HA FILLER. SERIOUSNESS CRITERIA INCLUDE THE RISK FOR PERMANENT DAMAGE TO BODY STRUCTURE AS THE EVENTS WERE LEFT UNTREATED. POTENTIAL CONTRIBUTORY FACTORS INCLUDE INJECTION TECHNIQUE. THIS CASE MEETS THE CRITERIA OF SERIOUSNESS AND CAUSALITY 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

    (B)(4) IS A LITERATURE REPORT RECEIVED 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) FEMALE PATIENT WHO UNDERWENT FILLER TREATMENT OF HER GLABELLAR REGION WITH AN UNSPECIFIED HYALURONIC ACID FILLER. THE TREATMENT WAS PERFORMED BY A COSMETICIAN. AN OCCLUSION OF THE LEFT SUPRATROCHLEAR ARTERY OCCURRED WITH SUBSEQUENT NECROSIS IN THE SUPPLY AREA OF THIS VESSEL. DURING THE TIMELY PRESENTATION OF THE COMPLICATION, IT WAS "DIAGNOSED" AS A HERPES INFECTION. THE COSMETICIAN DID NOT RECOMMEND TO SEEK MEDICAL ADVICE, AND FURTHER MEASURES WERE NOT TAKEN AT THAT TIME. THE PATIENT PRESENTED TO THE REPORTING PHYSICIAN TWO MONTHS AFTER THE INJECTION. AN ALREADY ATROPHIC SCAR HAD MEANWHILE MANIFESTED WHICH COULD ONLY BE TREATED WITH CARE PRODUCTS FOR SCARS (OUTCOME: RECOVERED/RESOLVED WITH SEQUELS). THE REPORTER DID NOT COMMENT ON CAUSALITY BUT STATED THAT AT THE TIME OF THE PRESENTATION OF THE COMPLICATION TO THE COSMETICIAN, A TREATMENT WITH HYALURONIDASE WOULD HAVE BEEN THE THERAPY OF CHOICE IN ORDER TO ATTEMPT A POSSIBLE REPERFUSION OF THE INFARCTED SKIN AREA.

    Additional Manufacturer Narrative · 1

    ENGINEERING EVALUATION: THE REPORTED EVENTS ARE EXPECTED WITH FILLER INJECTIONS. 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 EVENTS OF VASCULAR OCCLUSION, IMPLANT SITE NECROSIS, AND SCAR WERE CONSIDERED EXPECTED AND POSSIBLY RELATED TO THE TREATMENT WITH UNSPECIFIED HA FILLER. SERIOUSNESS CRITERIA INCLUDE THE RISK FOR PERMANENT DAMAGE TO BODY STRUCTURE AS THE EVENTS WERE LEFT UNTREATED. POTENTIAL CONTRIBUTORY FACTORS INCLUDE INJECTION TECHNIQUE. THIS CASE MEETS THE CRITERIA OF SERIOUSNESS AND CAUSALITY FOR EXPEDITED REPORTING TO THE REGULATORY AUTHORITIES. EXEMPTION: GALDERMA LABORATORIES L.P. IS SUBMITTING THIS REPORT ON BEHALF OF Q-MED AB. EXEMPTION NUMBER E2015005. CASE WAS SUBMITTED TO FDA ON 11-DEC-2017. LITERATURE ARTICLE WAS SUBMITTED IN FOLLOW UP SUBMISSION ON 19-DEC-2017.

    Description of Event or Problem · 1

    CASE REFERENCE NUMBER (B)(4) IS A LITERATURE REPORT RECEIVED 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) FEMALE PATIENT WHO UNDERWENT FILLER TREATMENT OF HER GLABELLAR REGION WITH AN UNSPECIFIED HYALURONIC ACID FILLER. THE TREATMENT WAS PERFORMED BY A COSMETICIAN. AN OCCLUSION OF THE LEFT SUPRATROCHLEAR ARTERY OCCURRED WITH SUBSEQUENT NECROSIS IN THE SUPPLY AREA OF THIS VESSEL. DURING THE TIMELY PRESENTATION OF THE COMPLICATION, IT WAS "DIAGNOSED" AS A HERPES INFECTION. THE COSMETICIAN DID NOT RECOMMEND TO SEEK MEDICAL ADVICE, AND FURTHER MEASURES WERE NOT TAKEN AT THAT TIME. THE PATIENT PRESENTED TO THE REPORTING PHYSICIAN TWO MONTHS AFTER THE INJECTION. AN ALREADY ATROPHIC SCAR HAD MEANWHILE MANIFESTED WHICH COULD ONLY BE TREATED WITH CARE PRODUCTS FOR SCARS (OUTCOME: RECOVERED/RESOLVED WITH SEQUELS). THE REPORTER DID NOT COMMENT ON CAUSALITY BUT STATED THAT AT THE TIME OF THE PRESENTATION OF THE COMPLICATION TO THE COSMETICIAN, A TREATMENT WITH HYALURONIDASE WOULD HAVE BEEN THE THERAPY OF CHOICE IN ORDER TO ATTEMPT A POSSIBLE REPERFUSION OF THE INFARCTED SKIN AREA. THIS CASE WAS SUBMITTED TO FDA ON 11-DEC-2019. THE LITERATURE ARTICLE WAS SUBMITTED IN FOLLOW-UP SUBMISSION ON 19-DEC-2017.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    884208 UNSPECIFIED HA FILLER IMPLANT, DERMAL, FOR AESTHETIC USE LMH GALDERMA QMED

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention| S