BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STRATTICE BY LIFECELL 10X16 CM CAT #1016002, LOT #SP100185-052

    MDR report key: 5942435 · Received September 7, 2016

    Report

    Report Number
    MW5064647
    Event Type
    Injury
    Date Received
    September 7, 2016
    Date of Event
    September 7, 2016
    Report Date
    September 7, 2016
    Manufacturer
    LIFECELL CORP.
    Product Code
    FTM
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    TRAM FLAP MEDICAL DEVICE USED FOR RECONSTRUCTION ON (B)(6) 2015. THE PROCEDURE WAS DONE WITH DR. (B)(6), PLASTIC SURGEON. ON (B)(6) 2016 AT (B)(6) HOSPITAL (B)(6). RECORDS ARE AT THE HOSPITAL AND DOCTOR'S OFFICE. I HAVE BEEN DISABLE SINCE THE SURGERY. IT'S HARD TO WALK, LAY DOWN, SIT UP, MOVE OR GO BACK TO MY LIFESTYLE. DOSE OR AMOUNT, FREQUENCY: INSTALL PERMANENTLY. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED? NO. IS THE PRODUCT COMPOUNDED? NO. IS THE PRODUCT OVER-THE-COUNTER? NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    586135 STRATTICE BY LIFECELL 10X16 CM CAT #1016002, LOT #SP100185-052 MESH SURGICAL FTM LIFECELL CORP. SP100185-052

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization| O| R| S ATORVASTATIN| FENOTIBRATE 54 MG 1 A DAY| LISINOPRIL HCTZ 10-12.5 MG 2 TIMES A DAY| METFORMIN 500 MG TWICE A DAY| TARTRATE 5 MG AS NEEDED | ZOLPIDEM