BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN STRATTICE

    MDR report key: 23512265 · Received November 10, 2025

    Report

    Report Number
    1000306051-2025-00110
    Event Type
    Injury
    Date Received
    November 10, 2025
    Date of Event
    October 7, 2025
    Report Date
    November 10, 2025
    Manufacturer
    LIFECELL
    Product Code
    FTM
    PMA / PMN Number
    K070560
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ARTICLE CITATION: HIDALGO DA, WEINSTEIN AL. SURGICAL TREATMENT OF CAPSULAR CONTRACTURE WITH ACELLULAR DERMAL MATRIX: 100 CONSECUTIVE CASES. PLASTIC AND RECONSTRUCTIVE SURGERY. PUBLISHED OCTOBER 2025:10.1097/PRS.0000000000012508. DOI:HTTPS://DOI.ORG/10.1097/PRS.0000000000012508. DUE TO LIMITED INFORMATION AVAILABLE ABOUT EACH REPORTABLE EVENT AND LACK OF SPECIFIC PATIENT AND PRODUCT INFORMATION IN THE LITERATURE ARTICLE, ONE COMPLAINT CASE IS BEING OPENED THAT IS REPRESENTATIVE OF ALL EVENTS FROM THE REFERENCED ARTICLE. THESE EVENTS ARE BEING REPORTED AS SERIOUS INJURIES DUE TO THE REPORTED CELLULITIS, SEROMA, AND CAPSULAR CONTRACTURE. MULTIPLE ATTEMPTS ARE BEING MADE FOR ADDITIONAL INFORMATION, INCLUDING LOT NUMBERS, GRAFT TISSUE DISPOSITION AND RELEVANT PATIENT FACTORS; HOWEVER, TO DATE NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. THE LOT NUMBERS ASSOCIATED WITH THESE EVENTS REMAIN UNKNOWN; THEREFORE, AN INTERNAL INVESTIGATION COULD NOT BE PERFORMED. NO GRAFT TISSUES WERE RETURNED FOR EVALUATION. BASED ON THE REPORTED INFORMATION, A RELATIONSHIP BETWEEN THE EVENTS AND THE STRATTICE GRAFT TISSUE CANNOT BE DETERMINED. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    ON 15/OCT/2025, ABBVIE RECEIVED A PUBLICATION FROM THE US TITLED "SURGICAL TREATMENT OF CAPSULAR CONTRACTURE WITH ACELLULAR DERMAL MATRIX: 100 CONSECUTIVE CASES¿. A RETROSPECTIVE COHORT STUDY OF 100 CONSECUTIVE PATIENTS SURGICALLY TREATED WITH STRATTICE ADM (ALLERGAN, IRVINE, CA) FOR CAPSULAR CONTRACTURE FROM 2014 TO 2024. COMPLICATIONS REPORTED: CONTRACTURE RECURRENCE: 10. SEROMAS REQUIRING DRAIN PLACEMENT: 3. HEMATOMAS REQUIRING OPERATIVE EVACUATION: 2. CELLULITIS: 1. PALPABLE ADM EDGES: 5. CELLULITIS: 1.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2582323 UNKNOWN STRATTICE MESH, SURGICAL FTM LIFECELL NI

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Female Required Intervention