BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILHOUETTE INSTALIFT

    MDR report key: 9217780 · Received October 22, 2019

    Report

    Report Number
    3007009755-2019-00007
    Event Type
    Injury
    Date Received
    October 22, 2019
    Report Date
    January 23, 2020
    Manufacturer
    SILHOUETTE LIFT INC.
    Product Code
    GAM
    PMA / PMN Number
    K163676
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    117

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER COMMENT: FOLLOWING A THOROUGH REVIEW OF BATCH RECORDS, NO MANUFACTURING DEVIATIONS WERE IDENTIFIED FOR LOT 0389-28 AND PRODUCTION WAS COMPLETED ACCORDING TO THE CORRECT MANUFACTURING SPECIFICATION. THERE HAVE BEEN NO OTHER ADVERSE EVENTS OF A SIMILAR NATURE REPORTED FOR LOT 0389-28. CONCLUSION POTENTIAL ROOT CAUSES MAY RELATE TO: NON-ASEPTIC TREATMENT CONDITIONS. POOR PATIENT AFTERCARE. TOO SUPERFICIAL PLACEMENT OF THE SUTURES. THE PATIENT'S PREVIOUS DERMAL FILLER TREATMENT. THERE IS NO EVIDENCE TO SUGGEST A PRODUCT DEFECT.

    Additional Manufacturer Narrative · 0

    MANUFACTURER COMMENT RETAINED SAMPLE TESTING HAS BEEN REQUESTED AND THE RESULTS WILL BE SUBMITTED WITHIN A FOLLOW-UP REPORT. CLINICAL COMMENT A COMPANY MEDICAL ADVISOR IS OF THE OPINION THAT THE INSERTION OF THE SUTURES OVER RECENTLY INJECTED FILLER TREATMENT MAY HAVE TRIGGERED AN INFLAMMATORY REACTION AND THAT THIS HAS INCREASED THE RISK OF INFECTION. CONCLUSION THE INVESTIGATION IS ONGOING AND THE INVESTIGATION CONCLUSION WILL BE PROVIDED WITHIN A FOLLOW-UP REPORT.

    Description of Event or Problem · 0

    ONE WEEK PRIOR TO THE PATIENT'S TREATMENT WITH SILHOUETTE INSTALIFT, THEY RECEIVED DERMAL FILLER TREATMENT.

    Additional Manufacturer Narrative · 1

    MANUFACTURER COMMENT: A REVIEW OF THE BATCH RECORDS HAS BEEN CONDUCTED WHICH CONFIRMS THAT LOT 0389-28 WAS MANUFACTURED AND RELEASED PER SET SPECIFICATIONS. THERE IS NO EVIDENCE OF A PRODUCT DEFECT. A BATCH TREND REVIEW SHOWS NO OTHER EVENTS OF A SIMILAR NATURE ASSOCIATED WITH THIS LOT. RETAINED SAMPLE TESTING HAS BEEN REQUESTED AND THE RESULTS WILL BE SUBMITTED WITHIN A FOLLOW-UP REPORT. CLINICAL COMMENT: THE PRACTITIONER MANAGING THE PATIENT'S EVENT COMMENTED THAT ONE OF THE SUTURES WAS PLACED TOO SUPERFICIALLY. TWO SINCLAIR MEDICAL ADVISORS ARE BOTH OF THE OPINION THAT THE PATIENT HAS EXPERIENCED AN INFECTION FOLLOWING TREATMENT WHICH IS LIKELY ATTRIBUTABLE TO POOR PATIENT AFTERCARE AND/OR NON-ASEPTIC TREATMENT CONDITIONS. CONCLUSION: THE PROBABLE ROOT CAUSE OF THE EVENT IS NON-ASEPTIC TREATMENT CONDITIONS AND/OR POOR PATIENT AFTERCARE. A POTENTIAL ROOT CAUSE MAY RELATE TO TOO SUPERFICIAL PLACEMENT OF THE SUTURES. (B)(4).

    Description of Event or Problem · 1

    A PATIENT UNDERWENT TREATMENT WITH SILHOUETTE INSTALIFT ON (B)(6) 2019. TWO SUTURES WERE INSERTED IN EACH SIDE OF THE FACE. ON AN UNKNOWN DATE, WITHIN 2 WEEKS OF TREATMENT, THE PATIENT REPORTED SYMPTOMS OF REDNESS, HEAT, ITCHING, SWEATS AND HOT FLASHES. ON (B)(6) 2019 THE PATIENT DEVELOPED A LUMP ON THE LEFT CHEEK THAT INCREASED IN SIZE OVER THE FOLLOWING TWO DAYS. A LOCAL PHYSICIAN PRESCRIBED ANTIBIOTICS TO TREAT THE ISSUE. FOLLOWING COMPLETION OF THE ANTIBIOTICS, THE LUMP CONTINUED TO INCREASE IN SIZE. THE PATIENT THEN REPORTED FEELING TENDERNESS AND PAIN NEAR THE HAIRLINE AND SWELLING ALONG THE SUTURE TRACK ON THE LEFT SIDE OF THE FACE. ON (B)(6) 2019 THE PHYSICIAN DRAINED AN SINGLE ABSCESS ON THE LEFT SIDE OF THE FACE. ON (B)(6) 2019 THE PHYSICIAN INSERTED A DRAIN INTO THE PATIENTS FACE. ON (B)(6) 2019 THE PHYSICIAN INSERTED ADDITIONAL DRAINS INTO THE PATIENT FACE. ON (B)(6) 2019 THE PATIENT USED A Q-TIP TO PRESS ALONG THE AFFECTED AREA AROUND THE DRAINS TO RELEASE FLUID. ON AN UNKNOWN DATE DURING THE WEEK COMMENCING THE (B)(6) 2019, THE PATIENT UNDERWENT REMOVAL OF TWO SUTURES FROM THE PRE-AURICULAR AREA ON THE LEFT SIDE OF THE FACE. FOLLOWING REMOVAL OF THE SUTURES THE PATIENT WAS PRESCRIBED ANTIBIOTICS AND WAS REPORTED TO BE IMPROVING. TREATMENT OF THE EVENT: THE PATIENT HAS BEEN PRESCRIBED ANTIBIOTIC TREATMENTS INCLUDING BACTRIM (TRIMETHOPRIM / SULFAMETHOXAZOLE), VANCOMYCIN, DOXYCYCLINE, AZITHROMYCIN, MOXIFLOXACIN AND CEFTRIAXONE. INCISION AND DRAINAGE OF THE AFFECTED AREA. THERMACARE TREATMENT (A DISPOSABLE HEATING PAD). REMOVAL OF TWO SUTURES ON THE LEFT SIDE OF THE FACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1012559 SILHOUETTE INSTALIFT SILHOUETTE INSTALIFT GAM SILHOUETTE LIFT INC. 0389-28

    Patients

    Seq Age Sex Outcome Treatment
    1 Other