BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK STYLE SCL

    MDR report key: 18833137 · Received March 4, 2024

    Report

    Report Number
    9617229-2024-03651
    Event Type
    Injury
    Date Received
    March 4, 2024
    Report Date
    March 27, 2024
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    PMA / PMN Number
    P020056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE EVENT OF WOUND DEHISCENCE 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/WILL BE REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THE REASON FOR REOPERATION IS: "WOUND PROBLEMS".

    Description of Event or Problem · 0

    ALLERGAN AESTHETICS RECEIVED A REPORT, VIA NBIR, OF A LEFT SIDE "CAPSULAR CONTRACTURE, BAKER GRADE II AND WOUND PROBLEMS". THE DEVICE HAS BEEN EXPLANTED AND REPLACED. A CAPSULECTOMY/CAPSULOTOMY WAS PERFORMED.

    Description of Event or Problem · 0

    ALLERGAN AESTHETICS RECEIVED, A REPORT. VIA NBIR, OF A LEFT SIDE "CAPSULAR CONTRACTURE, BAKER GRADE II. AND WOUND PROBLEMS". THE DEVICE HAS BEEN EXPLANTED AND REPLACED. A CAPSULECTOMY/CAPSULOTOMY WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    175599 UNK STYLE SCL PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention