BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 16212265 · Received January 19, 2023

    Report

    Report Number
    9617229-2023-00621
    Event Type
    Injury
    Date Received
    January 19, 2023
    Date of Event
    December 28, 2022
    Report Date
    May 3, 2023
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    UDI-DI
    05060191607339
    PMA / PMN Number
    P020056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE EVENT OF LYMPHADENOPATHY IS A PHYSIOLOGICAL COMPLICATION AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THIS EVENT. REASON FOR REOPERATION: LYMPHADENOPATHY. VISUAL ANALYSIS: DEVICE PHOTOGRAPH(S) FOR THE DEVICE RELATED TO THE REPORTED EVENT OF PAIN, FEVER, SEROMA-LATE, ANXIETY-PRODUCT/PROCEDURE, EDEMA, INFLAMMATION/IRRITATION, CARDIAC COMPLICATION-NDR, DEPRESSION-NDR, VARIED INJURIES-NDR, ISCHEMIA-NDR, AUTOIMMUNE/CONNECTIVE TISSUE DISORDERS-NDR, SENSATION INCREASE/DECREASE, INFECTION (LATE ONSET), LYMPHADENOPATHY, MALPOSITION, VISIBILITY/PALPABILITY REVIEWED ON 11-MAR-2023. VISUAL ANALYSIS OF THE PHOTOGRAPHS IDENTIFIED: PAIN: UNABLE TO CONFIRM AS IT IS A MEDICAL EVENT NOT RELATED TO THE DEVICE. FEVER: UNABLE TO CONFIRM AS IT IS A MEDICAL EVENT NOT RELATED TO THE DEVICE. SEROMA-LATE: UNABLE TO CONFIRM AS IT IS A MEDICAL EVENT NOT RELATED TO THE DEVICE. ANXIETY-PRODUCT/PROCEDURE: UNABLE TO CONFIRM AS IT IS A MEDICAL EVENT NOT RELATED TO THE DEVICE. EDEMA: UNABLE TO CONFIRM AS IT IS A MEDICAL EVENT NOT RELATED TO THE DEVICE. INFLAMMATION/IRRITATION: UNABLE TO CONFIRM AS IT IS A MEDICAL EVENT NOT RELATED TO THE DEVICE. CARDIAC COMPLICATION-NDR: UNABLE TO CONFIRM AS IT IS A MEDICAL EVENT NOT RELATED TO THE DEVICE. DEPRESSION-NDR: UNABLE TO CONFIRM AS IT IS A MEDICAL EVENT NOT RELATED TO THE DEVICE. VARIED INJURIES-NDR: UNABLE TO CONFIRM AS IT IS A MEDICAL EVENT NOT RELATED TO THE DEVICE. ISCHEMIA-NDR: UNABLE TO CONFIRM AS IT IS A MEDICAL EVENT NOT RELATED TO THE DEVICE. AUTOIMMUNE/CONNECTIVE TISSUE DISORDERS-NDR: UNABLE TO CONFIRM AS IT IS A MEDICAL EVENT NOT RELATED TO THE DEVICE. SENSATION INCREASE/DECREASE: UNABLE TO CONFIRM AS IT IS A MEDICAL EVENT NOT RELATED TO THE DEVICE. INFECTION (LATE ONSET): UNABLE TO CONFIRM AS IT IS A MEDICAL EVENT NOT RELATED TO THE DEVICE. LYMPHADENOPATHY: UNABLE TO CONFIRM AS IT IS A MEDICAL EVENT NOT RELATED TO THE DEVICE. MALPOSITION: UNABLE TO CONFIRM AS IT IS A MEDICAL EVENT NOT RELATED TO THE DEVICE. VISIBILITY/PALPABILITY: UNABLE TO CONFIRM AS IT IS A MEDICAL EVENT NOT RELATED TO THE DEVICE. IT IS NOT POSSIBLE TO DETERMINE THE LOT NUMBER OR CATALOG THROUGH THE PHOTOS PROVIDED. ADDITIONAL, CHANGED, AND/OR CORRECTED DATA: B5, B6, H6, H10.

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN COMPLETED. NO DEVIATIONS OR NON-CONFORMANCE'S NOTED. THE EVENT OF SEROMA (FLUID IN THE LEFT HEMITHORAX, FLUID IN THE LEFT SIDE, AND PRESENCE OF COLLECTION TOWARDS THE PERIPROSTHETIC MEDIAL QUADRANTS) IS A PHYSIOLOGICAL COMPLICATION AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THIS EVENT.  FURTHER INFORMATION FROM THE REPORTER REGARDING EVENT, PRODUCT, OR PATIENT DETAILS HAS BEEN REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.  REASON FOR REOPERATION:  SEROMA (FLUID IN THE LEFT HEMITHORAX, FLUID IN THE LEFT SIDE, AND PRESENCE OF COLLECTION TOWARDS THE PERIPROSTHETIC MEDIAL QUADRANTS).

    Additional Manufacturer Narrative · 0

    ADDITIONAL, CHANGED, AND/OR CORRECTED DATA: H6, H10 A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN COMPLETED. NO DEVIATIONS OR NON-CONFORMANCES NOTED.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL LATER REPORTED "THEY ARE GENERATING EDEMAS IN PATIENT¿S BODY" AND "PATIENT IS CONCERNED". HEALTHCARE PROFESSIONAL REPORTED IRRITATION AND NUMBNESS. DEVICE HAS BEEN EXPLANTED

    Description of Event or Problem · 0

    PATIENT REPORTED "TACHYCARDIA, DEPRESSION, HAIR LOSS, PAIN, TRANSIENT ISCHEMIA", "ASIA SYNDROME", AND "PAIN IN MY LEFT SIDE, WITH FLUID IN THE LEFT HEMITHORAX" VIA MRI AND ULTRASOUND, AND "FEVER." LATER, A HEALTHCARE PROFESSIONAL REPORTED "THEY ARE GENERATING EDEMAS IN PATIENT¿S BODY", "PATIENT IS CONCERNED", AND "IRRITATION AND NUMBNESS." THE DEVICE REMAINS IMPLANTED. THE EVENTS OF TACHYCARDIA, DEPRESSION, HAIR LOSS, PAIN, TRANSIENT ISCHEMIA, ASIA SYNDROME, THEY ARE GENERATING EDEMAS IN PATIENT¿S BODY, PATIENT IS CONCERNED, IRRITATION AND NUMBNESS, WERE CONSIDERED NON DEVICE RELATED.

    Description of Event or Problem · 0

    PATIENT REPORTED "TACHYCARDIA, DEPRESSION, HAIR LOSS, PAIN, TRANSIENT ISCHAEMIA", "ASIA SYNDROME", AND "PAIN IN MY LEFT SIDE, WITH FLUID IN THE LEFT HEMITHORAX, FEVER". HEALTHCARE PROFESSIONAL LATER REPORTED "THEY ARE GENERATING EDEMAS IN PATIENT¿S BODY" AND "PATIENT IS CONCERNED". HEALTHCARE PROFESSIONAL REPORTED IRRITATION AND NUMBNESS. DEVICE HAS BEEN REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    395005 INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) 2542741 05060191607339

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Female Required Intervention