BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 9597698 · Received January 16, 2020

    Report

    Report Number
    9617229-2019-23318
    Event Type
    Injury
    Date Received
    January 16, 2020
    Date of Event
    December 19, 2019
    Report Date
    November 25, 2020
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    UDI-DI
    10888628008502
    PMA / PMN Number
    P020056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    IN RESPONSE TO FDA REPORT NUMBER: MW 5092449. A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN COMPLETED. NO DEVIATIONS OR NON-CONFORMANCES NOTED.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE IV. PATIENT ADDITIONALLY REPORTED ""PROBLEMS WITH MY HANDS AND ARMS", "SWELLING", "REDNESS", "PALLOR", "CHANGE IN TEMPERATURE", "SEVERE PAIN", "SEVERE PAIN IN NECK", "EXTREME VASCULAR AND NEURO PROBLEMS IN MY UPPER EXTREMITIES", "UNABLE TO USE MY HANDS", "SEVERAL ACUTE BILATERAL POSTERIOR RIB FRACTURES WITHOUT TRAUMA OR INCIDENT", "RIB FRACTURES" AND "DEVELOPED SEVERE RIB PAIN." THESE EVENTS ARE NOT DEVICE RELATED. PATIENT ALSO REPORTED "DEVELOPED SEVERE BACK AND CHEST PAIN." DEVICE HAS BEEN EXPLANTED.

    Description of Event or Problem · 0

    PATIENT ADDITIONALLY REPORTED ""PROBLEMS WITH MY HANDS AND ARMS", "SWELLING", "REDNESS", "PALLOR", "CHANGE IN TEMPERATURE", "SEVERE PAIN", "SEVERE PAIN IN NECK", "EXTREME VASCULAR AND NEURO PROBLEMS IN MY UPPER EXTREMITIES", "UNABLE TO USE MY HANDS", "SEVERAL ACUTE BILATERAL POSTERIOR RIB FRACTURES WITHOUT TRAUMA OR INCIDENT", "RIB FRACTURES" AND "DEVELOPED SEVERE RIB PAIN." THESE EVENTS ARE NOT DEVICE RELATED. PATIENT ALSO REPORTED "DEVELOPED SEVERE BACK AND CHEST PAIN." DEVICE HAS BEEN EXPLANTED.

    Additional Manufacturer Narrative · 1

    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. 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. 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: CAPSULAR CONTRACTURE, BAKER GRADE IV.

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE IV. DEVICE REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    61811 INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) TRX-400 2885032 10888628008502

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention