BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNSPECIFIED HA FILLER

    MDR report key: 7783378 · Received August 14, 2018

    Report

    Report Number
    9710154-2018-00048
    Event Type
    Injury
    Date Received
    August 14, 2018
    Report Date
    August 14, 2018
    Manufacturer
    GALDERMA Q-MED
    Product Code
    LMH
    PMA / PMN Number
    P040024
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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: LOT NUMBER WAS NOT REPORTED. PHARMACOVIGILANCE COMMENT: THE SERIOUS EVENT OF BLINDNESS WAS CONSIDERED EXPECTED AND POSSIBLY RELATED TO THE TREATMENT WITH THE UNSPECIFIED HYALURONIC ACID (HA) FILLER. IT COULD NOT BE EXCLUDED THAT A GALDERMA PRODUCT HAD BEEN USED. SERIOUS CRITERIA INCLUDED PERMANENT DAMAGE TO A BODY STRUCTURE. POTENTIAL ETIOLOGIES INCLUDE EMBOLIC OCCLUSION OF HA MATERIAL IN THE OPHTHALMIC ARTERY AND CENTRAL RETINAL ARTERY DISTRIBUTION. THE CASE MEETS THE 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 RECEIVED ON 02-AUG-2018. THIS CASE WAS RECEIVED BY INTERNAL STAFF WHO HEARD TO A SECOND CASE OF BLINDNESS AT A HEARING YESTERDAY (B)(6) 2018. IT IS UNKNOWN WHAT BRAND OF FILLER WAS INVOLVED. THE FIRST CASE WAS REPORTED PREVIOUSLY - (B)(4). EMAIL FROM INTERNAL STAFF: "AT THE (B)(6) PARLIAMENTARY HEARING YESTERDAY BY (B)(6), IT WAS MENTIONED BY THE (B)(6) THAT TWO CASES OF BLINDNESS WITH DERMAL FILLERS HAVE BEEN REPORTED IN (B)(6) IN 2018." NO INFORMATION ABOUT MEDICAL HISTORY, CONCOMITANT MEDICATION, HISTORY OF ALLERGIES OR PREVIOUS FILLER TREATMENTS HAS BEEN PROVIDED. ON AN UNKNOWN DATE, THE PATIENT RECEIVED TREATMENT WITH AN UNSPECIFIED HA FILLER (UNKNOWN AMOUNT, LOT NUMBER, INJECTION TECHNIQUE AND NEEDLE TYPE). UNKNOWN TIME LATER, THE PATIENT EXPERIENCED BLINDNESS(BLINDNESS). TREATMENT FOR THE ADVERSE EVENT OR OTHER DETAILS WERE NOT REPORTED. OUTCOME AT THE TIME OF THE REPORT: BLINDNESS WAS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    624090 UNSPECIFIED HA FILLER IMPLANT, DERMAL, FOR AESTHETIC USE LMH GALDERMA Q-MED

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability