BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILHOUETTE INSTALIFT

    MDR report key: 6660141 · Received June 22, 2017

    Report

    Report Number
    3007009755-2017-00001
    Event Type
    Injury
    Date Received
    June 22, 2017
    Date of Event
    May 16, 2017
    Report Date
    May 23, 2017
    Manufacturer
    SILHOUETTE LIFT INC.
    Product Code
    GAM
    PMA / PMN Number
    K142061
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PHOTOGRAPHS PROVIDED SO FAR DO NOT CONFIRM THE SEVERITY OF THIS ISSUE. WHILE THERE DID NOT APPEAR TO BE A RISK OF A SERIOUS DETERIORATION IN HEALTH, THIS MATTER IS BEING REPORTED OUT OF CAUTION DUE TO THE ANTIBIOTIC INTERVENTION PROVIDED. (B)(4). DEVICE IMPLANTED AND IN SITU.

    Additional Manufacturer Narrative · 1

    AS THE PRODUCT WAS IMPLANTED IT WAS NOT RETURNED FOR INVESTIGATION. A REVIEW OF THE BATCH RECORDS WAS PERFORMED FOR THE LOT NUMBER THAT WAS PROVIDED BY THE PATIENT. THIS INDICATED THAT THE BATCH WAS MANUFACTURED AND RELEASED IN COMPLIANCE WITHIN THE SET SPECIFICATIONS. NO OTHER ADVERSE EVENTS WITH THE SAME PATIENT SYMPTOMS HAVE BEEN RECEIVED FOR THIS OR ANY OTHER INSTALIFT BATCH. SINCLAIR HAS RECEIVED A SMALL NUMBER OF QUALITY COMPLAINTS FOR THIS LOT NUMBER, WHERE THE CONES ON THE THREAD APPEARED TO BE MISSING OR NOT FIRMLY ATTACHED. SINCLAIR'S MEDICAL ADVISOR REVIEWED THE AVAILABLE INFORMATION AND ADVISED THAT IN THIS PARTICULAR CASE AND IN REFERENCE TO THE SYMPTOMS THE PATIENT HAD EXPERIENCED THERE WOULD NOT APPEAR TO BE A RELATIONSHIP TO THIS ISSUE. THE ADVISOR WAS OF THE OPINION THAT, THE COMBINATION OF PAIN, DEEP BRUISING PERSISTING OVER A FEW WEEKS, TINGLING SENSATION AND PAIN WITH MOVEMENTS (BRUSHING TEETH) POSSIBLY RELATES TO A DEEP TRAUMA IN THE CHEEK AT THE LEVEL OF VESSELS/NERVES. THIS SUGGESTS THAT THE PHYSICIAN'S TECHNIQUE MAY HAVE CONTRIBUTED TO THE CAUSE OF THE ISSUE. THE MEDICAL ADVISOR INDICATED THAT BRUISING CAN TAKE UP TO 3 TO 4 WEEKS TO RESOLVE IN THE DEEP TISSUES, AND CAN BE SENSITIVE TO THE TOUCH. THE OTHER ISSUES REPORTED SUCH AS DIMPLING AND THE TINGLING SENSATION, COULD, IN THEIR OPINION, POSSIBLY RELATE TO THE PLACEMENT OF THE THREADS I.E. THE TECHNIQUE USED BY THE DOCTOR TO PLACE THE THREADS AND THE PLANE IN WHICH THE THREADS ARE PLACED. THE 'POPPING' SOUND AT THE TEMPLE AREA, IN THE MEDICAL ADVISOR'S OPINION, COULD POSSIBLY RELATE TO THE UN-ANCHORING OF A CONE IN THE TEMPLE AREA, WHICH THEN COULD CONTRIBUTE TO THE LACK OF RESULTS OF THE TREATMENT DESCRIBED BY THE PATIENT. HE IS OF THE OPINION THAT THINGS SHOULD SETTLE FOR THIS PATIENT IN TIME. THIS MEDICAL ASSESSMENT WAS MADE BY A MEDICAL ADVISOR BASED ON THE VERY LIMITED INFORMATION PROVIDED BY THE PATIENT, AS SHE DID NOT WANT TO DIVULGE HER TREATING DOCTOR/CLINIC. THEREFORE THE MEDICAL RECORDS COULD NOT BE OBTAINED. FURTHER INFORMATION ABOUT THE PATIENT'S SITUATION WAS NOT RECEIVED. (B)(4).

    Description of Event or Problem · 1

    A PATIENT RECEIVED TREATMENT WITH INSTALIFT ON (B)(6) 2017. THE PATIENT RECEIVED 2 THREADS IN THE TEMPLE AREA ON EACH SIDE (PATTERNS UNKNOWN). THE PATIENT EXPERIENCED A POPPING SOUND ON ONE SIDE AT THE TEMPLE AREA IMMEDIATELY AFTER TREATMENT. SHE EXPERIENCED BRUISING AND DIMPLING AFTER THE TREATMENT; THIS HAS NOW SUBSIDED BUT IS NOT COMPLETELY GONE. THE PATIENT ALSO COMPLAINED OF BLACK DOTS AT THE ENTRY/EXIT PLACES; THE BLACK DOTS ARE APPARENTLY STILL THERE. THE DOCTOR WOULD APPEAR TO HAVE ADVISED THAT THESE ARE THE INCISION POINTS AND THAT THEY WOULD EVENTUALLY SUBSIDE. THE PATIENT HAS STATED THAT THEY EXPERIENCED TINGLING/PAIN WHEN BRUSHING HER TEETH, SMILES OR DOES FACIAL MOVEMENTS; THE DOCTOR SAID THIS WOULD ALSO SUBSIDE. SHE WAS FEELING PAIN ON THE RIGHT SIDE OF HER FACE WHERE THE BRUISING OCCURRED. THE PATIENT CONFIRMED THAT THE AREA IS PAINFUL TO THE TOUCH, HOWEVER OTHERWISE SHE DOESN'T FEEL IT. THE DOCTOR PRESCRIBED HER ANTIBIOTICS TO ADDRESS THE BRUISING AND PAIN. THERE IS STILL SOME DIMPLING, BUT IT IS NOT AS BAD AS IT WAS INITIALLY. IN GENERAL THE PATIENT FEELS THAT THE TREATMENT HAS NOT WORKED FOR HER.

    Description of Event or Problem · 1

    THIS FOLLOW UP REPORT REPRESENTS SINCLAIR CASE REFERENCE (B)(4) FINAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    441262 SILHOUETTE INSTALIFT SILHOUETTE INSTALIFT GAM SILHOUETTE LIFT INC. 0258-28

    Patients

    Seq Age Sex Outcome Treatment
    1 Other ANTIBIOTICS