BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PECTORAL IMPLANT

    MDR report key: 15562682 · Received October 6, 2022

    Report

    Report Number
    MW5112484
    Event Type
    Injury
    Date Received
    October 6, 2022
    Date of Event
    January 8, 2020
    Report Date
    October 4, 2022
    Manufacturer
    DSAART, LLC., DBA ALPHA AESTHETICS
    Product Code
    MIC
    UDI-DI
    B4905002035B0
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NV, US
    Reporter Occupation
    003
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    PATIENT HAVING REOCCURRING SEROMAS REQUESTED REPLACEMENT IMPLANT. IMPLANT WAS REMOVED AND DESTROYED PRIOR TO CONTACTING US ABOUT COMPLAINT. ALL RELEVANT INFORMATION REGARDING COMPLAINT ACQUIRED FROM DOCTOR. ON (B)(6) 2019, PATIENT DEVELOPED SEROMA; (B)(6) 2019 PT RETURNED, IMPLANT ADJUSTED (B)(6) 2019. DRAIN PLACE FOR CONTINUED SEROMA (B)(6) 2019. IMPLANT REMOVED (B)(6) 2020 CONTACTED US FOR REPLACEMENT IMPLANT. PATIENT DEVELOPED SEROMA POST - OP. CONTINUED SEROMAS REQUIRED IMPLANT REMOVAL AND REPLACEMENT UNABLE TO EXAMINE OR PERFORM TESTING ON EXPLANTED PRODUCT. DOCTOR REMOVED AND DESTROYED PRIOR TO CONTACTING US FOR REPLACEMENT. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2799858 PECTORAL IMPLANT IMPLANT, MUSCLE, PECTORALIS MIC DSAART, LLC., DBA ALPHA AESTHETICS B 18-10-011 B4905002035B0

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention GLUTEAL IMPLANT: (B)(6) 2019-(B)(6) 2019