BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 15946032 · Received December 8, 2022

    Report

    Report Number
    9617229-2022-22821
    Event Type
    Injury
    Date Received
    December 8, 2022
    Date of Event
    March 29, 2022
    Report Date
    April 14, 2023
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    UDI-DI
    05060191607674
    PMA / PMN Number
    P020056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN INITIATED. IF ANY NEW, CHANGED OR CORRECTED INFORMATION IS NOTED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED. 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: RUPTURE.

    Additional Manufacturer Narrative · 0

    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. DEVICE EVALUATION: VISUAL ANALYSIS OF THE PHOTOGRAPHS IDENTIFIED: -RUPTURE: OBSERVED AN OPENING IN ONE DEVICE BUT CANNOT PERFORM AN ASSESSMENT OF THE OPENING AS NO MICROSCOPIC ANALYSIS CAN BE PERFORMED AND THE OTHER DEVICE HAS RED BIOLOGICAL TISSUE IN THE SURFACE OF THE SHELL. IT IS NOT POSSIBLE TO DETERMINE THE LOT NUMBER OR CATALOG THROUGH THE PHOTOS PROVIDED.

    Additional Manufacturer Narrative · 0

    VISUAL ANALYSIS OF THE PHOTOGRAPHS IDENTIFIED: RUPTURE : OBSERVED BUT CANNOT PERFORM AN ASSESSMENT OF THE OPENING AS NO MICROSCOPIC ANALYSIS CAN BE PERFORMED. CAPSULAR CONTRACTURE: UNABLE TO OBSERVE AS IT IS A MEDICAL EVENT THAT IS NOT RELATED TO THE DEVICE. IT CANNOT BE DETERMINED WHICH DEVICE IS FOR THE LEFT OR RIGHT SIDE PER THE PHOTOS PROVIDED IT IS NOT POSSIBLE TO DETERMINE THE LOT NUMBER OR CATALOG THROUGH THE PHOTOS PROVIDED. REFER TO PS-QP-ONEV-115717: COVID-19 QUALITY PLAN - COMPLAINT HANDLING.

    Description of Event or Problem · 0

    PATIENT REPORTED "REQUESTING A FORM TO REPORT A DEFECTIVE PROSTHESIS¿. PHYSICIAN LATER REPORTED "MRI WHICH SHOWED AN INTRACAPSULAR RUPTURE". THIS RECORD IS RELATED TO THE LEFT SIDE . DEVICE HAS BEEN EXPLANTED AND REPLACED WITH A NON-ALLERGAN DEVICE.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE CAPSULAR CONTRACTURE BAKER GRADE IV AND DAMAGED.

    Description of Event or Problem · 0

    PATIENT REPORTED A "DEFECTIVE PROSTHESIS". PHYSICIAN LATER REPORTED "MRI WHICH SHOWED AN INTRACAPSULAR RUPTURE". THIS IS RELATED TO THE LEFT SIDE . IN ADDITION PHYSICIAN STATES: "BILATERAL CAPSULAR CONTRACTURE GRADE 4 AND DAMAGED LEFT SIDE IMPLANT".. DEVICE HAS BEEN EXPLANTED AND REPLACED WITH A NON-ALLERGAN DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2842955 INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) 2691263 05060191607674

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Female Required Intervention