BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILHOUETTE INSTALIFT

    MDR report key: 15976924 · Received December 14, 2022

    Report

    Report Number
    3007009755-2022-00002
    Event Type
    Injury
    Date Received
    December 14, 2022
    Date of Event
    September 16, 2022
    Report Date
    November 16, 2022
    Manufacturer
    SINCLAIR PHARMA US INC.
    Product Code
    GAM
    PMA / PMN Number
    K200140
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURING COMMENT: SINCLAIR HAVE NOT RECEIVED CONFIRMATION OF THE LOT NUMBER INVOLVED IN THIS EVENT. THE EVENT IS NOT INDICATIVE OF A BATCH RELATED ISSUE. THIS INVESTIGATION IS ON-GOING AND FURTHER DETAILS WILL BE PROVIDED IN A FOLLOW UP REPORT. (B)(4).

    Additional Manufacturer Narrative · 0

    MANUFACTURING COMMENT A BATCH INVESTIGATION CONFIRMS THAT LOT 0440-28 WAS MANUFACTURED AND RELEASED WITHIN SPECIFICATION ON 23-MAY-2022. THE COMPLAINTS DATABASE SHOWS THAT ONE OTHER ADVERSE EVENT HAS BEEN RECEIVED FOR THE BATCH, WHICH WAS ASSESSED AS MOST LIKELY RELATING TO A SUPERFICIAL INSERTION BY THE USER. THERE IS NO INDICATION OF ANY BATCH OR PRODUCT RELATED DEFECT. CLINICAL COMMENT: UTILISING MEDICAL EXPERTISE FROM THE LOCAL DISTRIBUTOR, THEY REMOTELY ASSESSED THE AVAILABLE INFORMATION AND ADVISED THE PRACTITIONER THAT IF THE SUTURES WERE PLACED USING A STERILE TECHNIQUE, THEN THE SUTURE WAS INADVERTENTLY PLACED SUPERFICIALLY CREATING A FOREIGN BODY INFLAMMATORY REACTION WHICH PERPETUATED AN INFECTION. CLINICAL COMMENT: UTILISING MEDICAL EXPERTISE FROM THE LOCAL DISTRIBUTOR, THEY REMOTELY ASSESSED THE AVAILABLE INFORMATION AND ADVISED THE PRACTITIONER THAT IF THE SUTURES WERE PLACED USING A STERILE TECHNIQUE, THEN THE SUTURE WAS INADVERTENTLY PLACED SUPERFICIALLY CREATING A FOREIGN BODY INFLAMMATORY REACTION WHICH PERPETUATED AN INFECTION. A COMPANY MEDICAL ADVISOR REMOTELY ASSESSED THE EVENT AND IS OF THE OPINION THAT THERE IS AN INFECTION, AS PER THE BACTERIOLOGIC EXAMINATION, AND IN HIS VIEW THE PATIENT HAS NOT EXPERIENCED A NODULE BUT A LATE ABSCESS THAT CAN BE RELATED TO THE SUTURE BEING PLACED TOO SUPERFICIALLY, OR THE DISTAL END WAS INCOMPLETELY TRIMMED AFTER INSERTION. THE CAUSE OF THE INFECTION IS NOT THE SILHOUETTE INSTALIFT SUTURE, OTHERWISE WE WOULD EXPECT INFECTIONS ALONG THE OTHER SUTURES.THE PRESENT COMPLICATION IS MOST LIKELY RELATED TO THE PROCEDURE (BOTH INSERTION TECHNIQUE AND ASEPSIS). OTHER COMMENT INFECTION, INFLAMMATION AND SWELLING ARE COMPLICATIONS THAT CAN OCCUR FOLLOWING SILHOUETTE INSTALIFT TREATMENT, AS OUTLINED IN THE PRODUCT INSTRUCTIONS FOR USE (JSP-CI-4211 REVA). THE SILHOUETTE RISK MANAGEMENT FILE (RMF) STATES THAT NODULES MAY OCCUR POST TREATMENT DUE TO TOO SUPERFICIAL PLACEMENT OF THE SUTURE. THE RMF STATES THAT AN ABSCESS MAY OCCUR IF THE PHYSICIAN DOES NOT MAINTAIN A STERILE ENVIRONMENT DURING TREATMENT. THE RMF STATES THAT TOO SUPERFICIAL PLACEMENT OF A SUTURE CAN ALSO LEAD TO A PATIENT EXPERIENCING A FOREIGN BODY REACTION AND INFLAMMATION. THE RMF LISTS THAT A PATIENT MAY EXPERIENCE AN INFECTION DUE TO: TOO SUPERFICIAL PLACEMENT OF THE SUTURE. INSUFFICIENT TRIMMING OF THE SUTURE. THE PHYSICIAN NOT ADEQUATELY STERILISING THE SKIN PRIOR TO TREATMENT. THE PHYSICIAN CONTAMINATING THE SUTURE WHICH IS SUBSEQUENTLY INSERTED INTO THE PATIENT. THE PHYSICIAN NOT MAINTAINING A STERILE ENVIRONMENT DURING TREATMENT. CONCLUSION: BASED ON THE INFORMATION AVAILABLE, THE MOST LIKELY ROOT CAUSE HAS BEEN DETERMINED AS USER ERROR; WHERE THE PHYSICIAN MAY HAVE INSERTED THE SUTURE TOO SUPERFICIALLY, NOT TRIMMED IT SUFFICIENTLY OR ELSE PERFORMED THE TREATMENT UNDER NON-ASEPTIC CONDITIONS.

    Description of Event or Problem · 0

    ON AN UNSPECIFIED DATE IN (B)(6) 2022, A PATIENT RECEIVED TREATMENT WITH SILHOUETTE INSTALIFT TO THE FACE. ON AN UNKNOWN DATE, THE PATIENT PRESENTED WITH TWO (2) NODULES ON THE RIGHT CHEEK. THEY WERE LATER PRESCRIBED ANTIBIOTICS TREATMENT, AND THE AFFECTED AREA WAS DRAINED. SINCLAIR ARE FOLLOWING UP FOR FURTHER INFORMATION REGARDING THE EVENT.

    Description of Event or Problem · 0

    ON (B)(6) 2022 A PATIENT RECEIVED TREATMENT WITH SILHOUETTE INSTALIFT TO THE FACE. SIX (6) SUTURES WERE PLACED BILATERALLY. ON (B)(6) 2022 THE PATIENT PRESENTED WITH AN INFLAMED NODULE AT THE RIGHT MARIONETTE AREA. THE NODULE WAS EXCISED, DRAINED AND A CULTURE WAS OBTAINED (THIS INDICATES THAT IT IS POTENTIALLY AN ABSCESS RATHER THAN A NODULE). ON (B)(6) 2022 THE CULTURE CAME BACK POSITIVE FOR STAPHYLOCOCCUS BACTERIA; AND THE PATIENT WAS SUBSEQUENTLY PLACED ON A COURSE OF DOXYCYCLINE. THE PATIENT HAS REPORTED TO NOT BE EXPERIENCING ANY PAIN, FEVER OR CHILLS. A PHOTOGRAPH HAS BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2023834 SILHOUETTE INSTALIFT SILHOUETTE INSTALIFT GAM SINCLAIR PHARMA US INC. 0440-28

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention