BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NO DEVICE

    MDR report key: 23256371 · Received October 9, 2025

    Report

    Report Number
    9617229-2025-17250
    Event Type
    Injury
    Date Received
    October 9, 2025
    Date of Event
    January 1, 2025
    Report Date
    October 23, 2025
    Manufacturer
    N/A
    Product Code
    -
    PMA / PMN Number
    -
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUED E.1 ADDRESS 1: (B)(6). ARTICLE CITATION: BAK EEF, GUDJONSDOTTIR LR, WELTZ TK, JØRGENSEN MG, BAK AN, FALK MW, NORLIN CB, TRAN JVQ, ØRHOLT M, HEMMINGSEN MN, HÖLMICH LR, ELBERG JJ, MIELKE LV, TRILLINGSGAARD J, VESTER-GLOWINSKI PV, LARSEN A, HERLY M. BREAST IMPLANT RUPTURE IS STRONGLY ASSOCIATED WITH CAPSULAR CONTRACTURE: AN INTRAPATIENT STUDY. PLAST RECONSTR SURG. 2025 SEP 16. DOI: 10.1097/PRS.0000000000012443. EPUB AHEAD OF PRINT. PMID: 40957074. ADDITIONAL AUTHOR CONTACTS: ERIK E. F. BAK, BMSC LINDA R. GUDJONSDOTTIR, BMSC TIM K. WELTZ, MD MADS G. JØRGENSEN, MD, PHD ANNA N. BAK, BMSC MARIA W. FALK, BMSC CAROLINE B. NORLIN, BMSC JOHN V. Q. TRAN, BSC MATHIAS ØRHOLT, MD MATHILDE N. HEMMINGSEN, MD, PHD PETER V. VESTER-GLOWINSKI, MD, PHD ANDREAS LARSEN, MD, PHD COPENHAGEN UNIVERSITY HOSPITAL, DEPARTMENT OF PLASTIC SURGERY AND BURNS TREATMENT, RIGSHOSPITALET, COPENHAGEN, DENMARK LISBET R. HÖLMICH, MD, DMSC COPENHAGEN UNIVERSITY HOSPITAL, DEPARTMENT OF PLASTIC AND RECONSTRUCTIVE SURGERY, HERLEV AND GENTOFTE, COPENHAGEN, DENMARK UNIVERSITY OF COPENHAGEN, DEPARTMENT OF CLINICAL MEDICINE, COPENHAGEN, DENMARK JENS J. ELBERG, MD AMALIEKLINIKKEN, COPENHAGEN, DENMARK LOUISE V. MIELKE, MD ALERIS, COPENHAGEN, DENMARK JESPER TRILLINGSGAARD, MD AK NYGART, COPENHAGEN, DENMARK CORRESPONDENCE AUTHOR, ADDITIONAL CONTACT: MIKKEL HERLY, MD, PHD UNIVERSITY OF COPENHAGEN, DEPARTMENT OF IMMUNOLOGY AND MICROBIOLOGY, COPENHAGEN, DENMARK 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. THE REASON FOR REOPERATION: RUPTURE, CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN.

    Additional Manufacturer Narrative · 0

    THERE IS NO DEVICE IN THIS RECORD TO REPORT AGAINST AS EVENTS AND DEVICE HAVE BEEN CAPTURED IN A DIFFERENT RECORD. THIS IS A DUPLICATE RECORD. INFORMATION IS NOW BEING REPORTED IN MANUFACTURE REPORT NUMBER : 9617229-2025-17255 ALL INFORMATION RECORDED IN THIS RECORD HAS BEEN TRANSFERRED TO THE CURRENT ACTIVE RECORD.

    Description of Event or Problem · 0

    LITERATURE ARTICLE TITLED "BREAST IMPLANT RUPTURE IS STRONGLY ASSOCIATED WITH CAPSULAR CONTRACTURE: AN INTRA-PATIENT STUDY" REPORTED THE EVENT OF IMPLANT RUPTURE, CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN, COSMETIC REASON AND BREAST IMPLANT ILLNESS IN A STUDY CONDUCTED IN 105 PATIENTS. THIS RECORD IS FOR UNKNOWN SIDE. DEVICE STATUS IS UNKNOWN.

    Description of Event or Problem · 0

    DUPLICATE RECORD. THERE IS NO LONGER A COMPLAINT AGAINST A DEVICE. INFORMATION IS BEING REPORTED IN ANOTHER RECORD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2509195 NO DEVICE - - NI

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Unknown Required Intervention