BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 16195780 · Received January 18, 2023

    Report

    Report Number
    9617229-2023-00369
    Event Type
    Injury
    Date Received
    January 18, 2023
    Date of Event
    January 1, 2022
    Report Date
    August 31, 2023
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    UDI-DI
    05060191606547
    PMA / PMN Number
    P020056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    CLARIFICATION TO A2: DATE OF BIRTH: (B)(6) 1989. THE EVENT OF CAPSULAR CONTRACTURE IS A PHYSIOLOGICAL COMPLICATION AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THIS EVENT.

    Additional Manufacturer Narrative · 0

    CLARIFICATION TO D9 AND H3: PLEASE DISREGARD AS THE DEVICE WAS NOT RECEIVED, ONLY PHOTOGRAPHS WERE PROVIDED FOR EVALUATION. DEVICE PHOTOGRAPH(S) FOR THE DEVICE RELATED TO THE REPORTED EVENT OF RUPTURE, CAPSULAR CONTRACTURE, LUMP/NODULE-NDR, PRURITUS, PAIN, VARIED INJURIES-NDR, DEPRESSION-NDR AND FEVER-NDR WAS REVIEWED ON JULY 10, 2023. IT IS NOT POSSIBLE TO DETERMINE THE LOT NUMBER OR CATALOG NUMBER THROUGH THE PHOTOS PROVIDED. VISUAL ANALYSIS OF THE DEVICE PHOTOGRAPHS IDENTIFIED: ¿ LUMP/NODULE-NDR: NOT APPLICABLE AS THE EVENT IS NOT RELATED TO THE DEVICE. ¿ PRURITUS: UNABLE TO OBSERVE SINCE IT IS NOT RELATED TO THE DEVICE. ¿ PAIN: UNABLE TO OBSERVE SINCE IT IS NOT RELATED TO THE DEVICE. ¿ VARIED INJURIES-NDR: NOT APPLICABLE AS THE EVENT IS NOT RELATED TO THE DEVICE. ¿ DEPRESSION-NDR: NOT APPLICABLE AS THE EVENT IS NOT RELATED TO THE DEVICE. ¿ FEVER-NDR: NOT APPLICABLE AS THE EVENT IS NOT RELATED TO THE DEVICE. ¿ CAPSULAR CONTRACTURE: UNABLE TO OBSERVE SINCE IT IS NOT RELATED TO THE DEVICE. ¿ RUPTURE: OBSERVED BUT CANNOT PERFORM AN ASSESSMENT OF THE OPENING AS NO MICROSCOPIC ANALYSIS CAN BE PERFORMED. NO ADDITIONAL OBSERVATIONS WERE CARRIED OUT. NO FURTHER ACTIONS ARE REQUIRED AS NO MANUFACTURING ISSUES ARE OBSERVED.

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN COMPLETED. NO DEVIATIONS OR NON-CONFORMANCES NOTED. FURTHER INFORMATION FROM THE REPORTER REGARDING EVENT, PRODUCT, OR PATIENT DETAILS HAS BEEN REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THE REASON FOR REOPERATION IS: "LUMP / KNOT FORMATION AND RIGHT SIDE DEVICE RUPTURE".

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED "SLEEP DISORDER", "RESTLESSNESS", "DEPRESSION", "FEVER", " POST BREAST AUGMENTATION, CAPSULAR FIBROSIS AND DEFECTIVE RIGHT IMPLANT". DEVICE HAS BEEN EXPLANTED AND REPLACED WITH NON-ALLERGAN DEVICE.

    Description of Event or Problem · 0

    BAKER GRADE IS UNKNOWN FOR THE "CAPSULAR FIBROSIS". PATIENT ADDITIONALLY REPORTED "FELT ITCHINESS, FOLLOWED BY PAIN, IN THE CHEST AREA" AND AN "ALTERED BREAST SHAPE". THE EVENTS OF "LUMP / KNOT FORMATION", "SLEEP DISORDER", "RESTLESSNESS", "DEPRESSION", AND "FEVER" ARE NOT DEVICE RELATED.

    Description of Event or Problem · 0

    PATIENT HAS REPORTED "LUMP / KNOT FORMATION AND RIGHT SIDE DEVICE RUPTURE". EXPLANT STATUS IS UNKNOWN AT THIS TIME.

    Description of Event or Problem · 0

    PATIENT HAS REPORTED "LUMP / KNOT FORMATION AND RIGHT SIDE DEVICE RUPTURE." EXPLANT STATUS IS UNKNOWN AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    14621 INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) 3086801 05060191606547

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Female Required Intervention