BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK SALINE IMPLANT

    MDR report key: 11839033 · Received May 17, 2021

    Report

    Report Number
    9617229-2021-16584
    Event Type
    Injury
    Date Received
    May 17, 2021
    Manufacturer
    NON-ALLERGAN MANUFACTURER
    Product Code
    FWM
    PMA / PMN Number
    P990074
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SUPPLEMENTAL MEDWATCH BEING SUBMITTED DUE TO ERROR IN G3 OF PREVIOUSLY SUBMITTED REPORT. ADDITIONALLY, UPON FURTHER INVESTIGATION THIS DEVICE WAS FOUND TO BE NON-ALLERGAN.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED BILATERAL SALINE TEXTURED IMPLANT DEVICE REMOVAL. THE DEVICE HAS BEEN EXPLANTED. HEALTHCARE PROFESSIONAL REPORTED UNSPECIFIED SIDE RUPTURE, SEROMA AND TENDERNESS.

    Additional Manufacturer Narrative · 1

    THE EVENT OF "SEROMA-LATE" 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: SEROMA-LATE, RUPTURE AND "TENDERNESS." THIS IS A KNOWN POTENTIAL ADVERSE EVENT ADDRESSED IN THE PRODUCT LABELING.

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTED RUPTURE, SALINE TEXTURED IMPLANT DEVICE REMOVAL, SEROMA AND TENDERNESS FOR AN UNKNOWN SIDE. MANUFACTURER OF DEVICE IS UNKNOWN. DEVICE WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    734009 UNK SALINE IMPLANT PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM NON-ALLERGAN MANUFACTURER NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention