BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTEFILL DERMAL FILLER

    MDR report key: 5371814 · Received January 15, 2016

    Report

    Report Number
    3003707320-2016-00001
    Event Type
    Injury
    Date Received
    January 15, 2016
    Date of Event
    March 1, 2013
    Report Date
    January 13, 2016
    Manufacturer
    SUNEVA MEDICAL, INC.
    Product Code
    LMH
    PMA / PMN Number
    P020012
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBERS, DATES IMPLANTED, AND EXPIRATION DATES OF THE SYRINGES USED IN THE PATIENT'S ARTEFILL PROCEDURES ARE AS FOLLOWS: F111019, 1 SYRINGE INJECTED ON (B)(6) 2011, EXPIRATION DATE: 09/2012 F111036, 2 SYRINGES INJECTED ON (B)(6) 2011, EXPIRATION DATE: 12/2012 F111041, 3 SYRINGES INJECTED ON (B)(6) 2011, EXPIRATION DATE: 12/2012 F111045, 1 SYRINGE INJECTED ON (B)(6) 2011, EXPIRATION DATE: 12/2012 F111050, 1 SYRINGE INJECTED ON (B)(6) 2011, EXPIRATION DATE: 02/2013 F111062, 2 SYRINGES INJECTED ON (B)(6) 2012, EXPIRATION DATE: 02/2013 F111063, 2 SYRINGES INJECTED ON (B)(6) 2012, EXPIRATION DATE: 03/2013 F121038, 1 SYRINGE INJECTED ON (B)(6) 2013, EXPIRATION DATE: 01/2014 PER THE DOCTOR'S OFFICE, THE EXPLANT PROCEDURE FOR THE GRANULOMA WAS PERFORMED ON 2 SEPARATE DATES: (B)(6) 2015. ADDITIONAL NARRATIVE: REVIEW OF BATCH MANUFACTURING RECORDS FOR ALL REPORTED LOTS WAS CONDUCTED. PRODUCT WAS MANUFACTURED IN ACCORDANCE WITH APPROVED WORK INSTRUCTIONS AND MET ACCEPTANCE CRITERIA AT THE TIME OF PRODUCT RELEASE. ALL LOTS ARE EXPIRED; THEREFORE A REVIEW OF RETAINED LOT SAMPLES COULD NOT BE CONDUCTED. THE INJECTION LOCATIONS (PERI-ORAL AND PERI-OCULAR) ARE OFF-LABEL FOR ARTEFILL AND OF WHICH THE INJECTING PHYSICIAN IS AWARE. THE PATIENT WAS INJECTED WITH ~10.4CC'S (0.8CC PER SYRINGE) OF ARTEFILL. PER ARTEFILL INSTRUCTIONS FOR USE, THE SAFETY OF INJECTING GREATER AMOUNTS THAN 3.5CC PER TREATMENT SITE OR 8.9CC OVERALL HAS NOT BEEN ESTABLISHED. GRANULOMA (AND THE POTENTIAL FOR EXCISION) IS AN ANTICIPATED PATIENT EVENT THAT IS DOCUMENTED IN THE ARTEFILL IFU. CLINICAL STUDIES SUPPORT THAT THESE ISSUES MAY RESOLVE OVER TIME WITH OR WITHOUT TREATMENT.

    Description of Event or Problem · 1

    THE PATIENT REQUIRED SURGERY AS THE ONLY RECOURSE TO RESOLVE THE PATIENT'S GRANULOMA. ON (B)(6) 2015, THE DOCTOR CALLED (B)(6) TO REPORT A PATIENT WITH GRANULOMA. ON (B)(6) 2015, THE DOCTOR PROVIDED INJECTION INFORMATION: THE PATIENT HAD PREVIOUSLY BEEN INJECTED WITH ARTEFILL IN 8 PROCEDURES OVER THE COURSE OF 2 YEARS (FROM (B)(6) 2011 TO (B)(6) 2013) WITH A TOTAL OF 13 SYRINGES (~10.4CC). THE PATIENT FIRST PRESENTED WITH GRANULOMA IN (B)(6) 2013. THE PATIENT'S GRANULOMA WAS LOCATED IN THE PERI-OCULAR AND PERI-ORAL AREAS. ON (B)(6) 2015, THE DOCTOR'S OFFICE REPORTED THAT TREATMENT FOR THE GRANULOMA'S HAD INITIATED WITH INTRALESIONAL KENALOG AND 5FU. ON (B)(6) 2015, THE DOCTOR'S OFFICE REPORTED THAT THE INTRALESIONAL TREATMENT WAS DISCONTINUED BECAUSE IT WAS CONSIDERED NOT EFFECTIVE, SURGERY WAS THE ONLY RECOURSE AND THE PATIENT WAS NOW RECOVERING AFTER SURGERY. GRANULOMA WAS REMOVED FROM BOTH PERI-OCULAR AND PERI-ORAL AREAS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27907 ARTEFILL DERMAL FILLER IMPLANT, DERMAL, FOR AESTHETIC USE LMH SUNEVA MEDICAL, INC. AF0508 ALL LOTS/DATES IN SECTION H10

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention