BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 133 TISSUE EXPANDER

    MDR report key: 12836804 · Received November 18, 2021

    Report

    Report Number
    9617229-2021-57636
    Event Type
    Injury
    Date Received
    November 18, 2021
    Date of Event
    January 1, 2021
    Report Date
    November 18, 2021
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    LCJ
    PMA / PMN Number
    K862203
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE EVENT OF INFECTION 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. REASON FOR REOPERATION: INFECTION (UNKNOWN ONSET).

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED "THE MOVEMENT OF IMP TO THE DORSAL SIDE WAS CONFIRMED IN 2 CASES OF TE INFECTION, 1 CASE OF HEMATOMA, AND CASE OF COMBINED USE WITH LD." UNKNOWN SIDE. THE STATUS OF DEVICE IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1733300 STYLE 133 TISSUE EXPANDER EXPANDER, SKIN, INFLATABLE LCJ ALLERGAN (COSTA RICA) NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention