BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN VLOC PRODUCT

    MDR report key: 9909932 · Received April 1, 2020

    Report

    Report Number
    1219930-2020-01489
    Event Type
    Injury
    Date Received
    April 1, 2020
    Date of Event
    May 21, 2015
    Report Date
    April 1, 2020
    Manufacturer
    COVIDIEN LP LLC NORTH HAVEN
    Product Code
    GAM
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). TITLE: POWER-ASSISTED LIPOSUCTION MAMMAPLASTY (PALM): A NEW TECHNIQUE FOR BREAST REDUCTION SOURCE AESTHETIC SURGERY JOURNAL, VOLUME 36, 2016 (35¿48) ARTICLE NUMBER: 1 DATE OF PUBLICATION: 24 JULY 2015. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO THE LITERATURE SOURCE OF A STUDY PERFORMED BETWEEN JANUARY 2008 TO JANUARY 2012 ABOUT POWER-ASSISTED LIPOSUCTION MAMMAPLASTY, 150 PATIENTS (300 BREASTS) UNDERWENT POWER-ASSISTED LIPOSUCTION MAMMAPLASTY FOR BREAST REDUCTION. 180 SUTURES WERE USED FOR GLANDULAR SUSPENSION AND WOUND CLOSURE. REVISIONAL SURGERY WAS PERFORMED IN 9 PATIENTS. 2 PATIENTS HAD PARTIAL AREOLAR NECROSIS. 6 BREASTS HAD WOUND INFECTION. 3 BREASTS HAD WOUND DEHISCENCE. 9 BREASTS HAD SEROMA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    374374 UNKNOWN VLOC PRODUCT SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID GAM COVIDIEN LP LLC NORTH HAVEN UNKNOWN VLOC PRODUCT

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Required Intervention