BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK TISSUE EXPANDER

    MDR report key: 18007173 · Received October 25, 2023

    Report

    Report Number
    9617229-2023-17796
    Event Type
    Injury
    Date Received
    October 25, 2023
    Date of Event
    September 27, 2023
    Report Date
    October 25, 2023
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    LCJ
    PMA / PMN Number
    K862203
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ARTICLE CITATION: WALKER JN, HANSON BM, HUNTER T, SIMAR SR, DURAN RAMIREZ JM, OBERNUEFEMANN CLP, PARIKH RP, TENENBAUM MM, MARGENTHALER JA, HULTGREN SJ, MYCKATYN TM. A PROSPECTIVE RANDOMIZED CLINICAL TRIAL TO ASSESS ANTIBIOTIC POCKET IRRIGATION ON TISSUE EXPANDER BREAST RECONSTRUCTION. MICROBIOL SPECTR. 2023 SEP 27;11(5):E0143023. DOI: 10.1128/SPECTRUM.01430-23. EPUB AHEAD OF PRINT. PMID: 37754546; PMCID: PMC10581127. CONTINUED E.1. FACILITY NAME: (B)(6) MEDICAL SCHOOL. CONTINUED H.6. HEALTH EFFECT - IMPACT CODE: F2201. THE EVENT OF INFECTION (UNKNOWN ONSET) 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 WILL BE REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. REASON FOR REOPERATION: "CLINICAL INFECTION, BACTERIAL ABUNDANCE, AND RELATIVE MICROBIOME COMPOSITION".

    Description of Event or Problem · 0

    THROUGH JOURNAL ARTICLE "A PROSPECTIVE RANDOMIZED CLINICAL TRIAL TO ASSESS ANTIBIOTIC POCKET IRRIGATION ON TISSUE EXPANDER BREAST RECONSTRUCTION" 16 PATIENTS UNDERWENT POST-MASTECTOMY BREAST RECONSTRUCTION INITIATED WITH A TISSUE EXPANDER (TE). BIOLOGIC AND PROSTHETIC SPECIMENS PROCURED BOTH AT THE TIME OF MASTECTOMY AND DURING TE REMOVAL MONTHS LATER WERE ANALYZED. OUTCOMES INCLUDED CLINICAL INFECTION, BACTERIAL ABUNDANCE, AND RELATIVE MICROBIOME COMPOSITION. AFFECTED SIDES ARE UNKNOWN. DEVICES HAVE BEEN EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1926387 UNK TISSUE EXPANDER EXPANDER, SKIN, INFLATABLE LCJ ALLERGAN (COSTA RICA) NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention