BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN - CAPROSYN

    MDR report key: 8504835 · Received April 11, 2019

    Report

    Report Number
    9612501-2019-00761
    Event Type
    Injury
    Date Received
    April 11, 2019
    Date of Event
    September 20, 2009
    Report Date
    April 11, 2019
    Manufacturer
    DAVIS & GECK CARIBE LTD
    Product Code
    GAM
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TITLE A DOUBLE-BLIND CONTROLLED TRIAL OF POLYGLYTONE 6211 VERSUS POLIGLECAPRONE 25 FOR USE IN BODY CONTOURING SOURCE ANNALS OF PLASTIC SURGERY, VOLUME 65, 2010 (124-128) ARTICLE NUMBER: 2 DATE OF PUBLICATION: 20 SEPTEMBER 2009. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO LITERATURE WITH A DOUBLE-BLIND PROSPECTIVE RANDOMIZED STUDY, THERE WERE 91 PATIENTS RANGING FROM 18 YEARS OLD AND ABOVE WHO HAD UNDERGONE BODY CONTOURING. THIS PROCEDURE INCLUDES ABDOMINOPLASTY, THIGH LIFT, LOWER BODY LIFT, MASTOPEXY, BREAST REDUCTION, CORRECTION OF GYNECOMASTIA, OR BRACHIOPLASTY. EACH PATIENT RECEIVED TWO DIFFERENT SUTURE MATERIALS FOR INTERRUPTING DEEP DERMAL CLOSURE. POST-OPERATIVELY, PATIENTS HAD EXPERIENCE SEVERAL ADVERSE EVENTS SUCH AS DEHISCENCE(8%), SEROMA (3%), NECROSIS (3%) AND CELLULITIS (1%).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299447 UNKNOWN - CAPROSYN SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID GAM DAVIS & GECK CARIBE LTD UNKNOWN - CAPROSYN

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Other