BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK MAMMARY IMPLANT

    MDR report key: 19829589 · Received July 25, 2024

    Report

    Report Number
    9617229-2024-17598
    Event Type
    Injury
    Date Received
    July 25, 2024
    Date of Event
    June 7, 2024
    Report Date
    July 25, 2024
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FWM
    PMA / PMN Number
    P990074
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CLARIFICATION: SECTION D, IT IS NOT KNOWN WHAT FILL DEVICES ARE: SILICONE GEL OR SALINE, DEFAULTED TO SALINE. IT IS ALSO NOT KNOWN WHICH DEVICE WERE ROUND OR ANATOMICAL IN SHAPE OR TEXTURED VS. NON-TEXTURED OR THE MANUFACTURER ASSOCIATED WITH THOSE PROVIDED PARAMETERS. ARTICLE CITATION: HUYGHEBAERT, T.A., WALLNER, C. & MONTEMURRO, P. IMPLEMENTATION OF A MACHINE LEARNING APPROACH EVALUATING RISK FACTORS FOR COMPLICATIONS AFTER SINGLE-STAGE AUGMENTATION MASTOPEXY. AESTH PLAST SURG (2024). HTTPS://DOI.ORG/10.1007/S00266-024-04142-7. AUTHORS AND AFFILIATIONS: DEPARTMENT OF PLASTIC SURGERY, BG UNIVERSITY HOSPITAL BERGMANNSHEIL, RUHR UNIVERSITY BOCHUM, BÜRKLE-DE-LA-CAMP PLATZ 1, 44789, BOCHUM, GERMANY TOM ALEXANDER HUYGHEBAERT & CHRISTOPH WALLNER. AKADEMIKLINIKEN, STORÄNGSVÄGEN 10, 11541, STOCKHOLM, SWEDEN PAOLO MONTEMURRO. THE EVENTS OF CAPSULAR CONTRACTURE, SEROMA, INFECTION AND MIGRATION ARE PHYSIOLOGICAL COMPLICATION AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THESE EVENTS. 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: CAPSULAR CONTRACTURE, SEROMA-LATE, INFECTION (UNKNOWN ONSET) AND MIGRATION (ROTATION, BOTTOMING OUT).

    Description of Event or Problem · 0

    LITERATURE ARTICLE, "IMPLEMENTATION OF A MACHINE LEARNING APPROACH EVALUATING RISK FACTORS FOR COMPLICATIONS AFTER SINGLE-STAGE AUGMENTATION MASTOPEXY", DETAILED A RETROSPECTIVE DATA ANALYSIS OF THE FOLLOWING POST-OPERATIVE COMPLICATIONS; ROTATION, CAPSULAR CONTRACTURE(UNKNOWN GRADE), BOTTOMING OUT, SEROMA, HEMATOMA, DOUBLE BUBBLE, INFECTION, 2 PATIENTS EXPERIENCED BOTH CAPSULAR CONTRACTURE AND POSTOPERATIVE HEMATOMA. DEVICE STATUS IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253757 UNK MAMMARY IMPLANT PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM ALLERGAN (COSTA RICA) NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention