BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK MAMMARY IMPLANT

    MDR report key: 12789189 · Received November 10, 2021

    Report

    Report Number
    9617229-2021-56538
    Event Type
    Injury
    Date Received
    November 10, 2021
    Date of Event
    March 15, 2021
    Report Date
    November 10, 2021
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FWM
    PMA / PMN Number
    P990074
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ARTICLE CITATION: HYEONJUNG YEO, DONGKYU LEE, JIN SOO KIM, PIL SEON EO, DONG KYU KIM, JOON SEOK LEE, KI TAE KWON, JEEYEON LEE, HO YONG PARK, JUNG DUG YANG, ¿STRATEGY FOR SALVAGING INFECTED BREAST IMPLANTS: LESSONS FROM THE RECOVERY OF SEVEN CONSECUTIVE PATIENTS¿, ARCHIVES OF PLASTIC SURGERY 2021; 48:165-174. (B)(4). THE EVENTS OF INFECTION (EARLY ONSET), SEROMA, NECROSIS, CAPSULAR CONTRACTURE (GRADE UNKNOWN) ARE PHYSIOLOGICAL COMPLICATIONS 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 WILL BE REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. REASON FOR REOPERATION: INFECTION (EARLY ONSET), SEROMA, NECROSIS, RUPTURE CAPSULAR CONTRACTURE (GRADE UNKNOWN).

    Description of Event or Problem · 0

    THROUGH JOURNAL ARTICLE TITLED ¿STRATEGY FOR SALVAGING INFECTED BREAST IMPLANTS: LESSONS FROM THE RECOVERY OF SEVEN CONSECUTIVE PATIENTS¿, REPORTED "SEVERE INFECTION", "FLAP NECROSIS", "HEMATOMA", "SEROMA", "IMPLANT RUPTURE" AND "CAPSULAR CONTRACTURE GRADE UNKNOWN". AFFECTED SIDE IS UNKNOWN. SEVEN PATIENTS TREATED WITH ANTIBIOTIC THERAPY, ANTIBIOTIC LAVAGE AND IMPLANT EXCHANGE. ONE PATIENT WITH A METHICILLIN-RESISTANT INFECTION SHOWED NO RESPONSE TO ANTIBIOTIC THERAPY AND DRAINAGE, AND THUS, THE DEVICE WAS EXPLANTED. OF THE 8 PATIENTS WITH INFECTIONS, 3 HAD RECEIVED CONCURRENT CHEMO-RADIOTHERAPY, AND 2 HAD RECEIVED CHEMOTHERAPY ALONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1686774 UNK MAMMARY IMPLANT PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM ALLERGAN (COSTA RICA) NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention