BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLODERM

    MDR report key: 8483003 · Received April 3, 2019

    Report

    Report Number
    MW5085578
    Event Type
    Injury
    Date Received
    April 3, 2019
    Date of Event
    February 24, 2017
    Report Date
    April 1, 2019
    Manufacturer
    ALLERGAN / LIFECELL
    Product Code
    FTL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    BILATERAL MASTECTOMIES WITH IMMEDIATE RECONSTRUCTION WITH ALLODERM SLING. RADIATION TO CANCER SIDE, 16 MONTHS WITH EXPANDERS, PAIN ENTIRE TIME. FOUR WEEKS AFTER EXCHANGE SURGERY "INFECTION" TO CANCER SIDE, 5 DAYS IN HOSP WITH IV ABX. C-DIFF INFECTION DUE TO ABX. STILL WITH PAIN. FAT GRAFTING TO BOTH RESULTING IN SEROMA / HEMATOMA TO CANCER SIDE LEADING TO IMPLANT REMOVAL. ONCE REMOVED MY PS FOUND THE ALLODERM HAD NOT "TAKEN" AND WAS BUNCHED UP AND ROLLED, SEE BELOW. PAIN NOW IMPROVED- TAKING LEXAPRO WITH GOOD RESULTS. I THINK I WILL CONTACT THE FDA. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270507 ALLODERM MESH, SURGICAL, POLYMERIC FTL ALLERGAN / LIFECELL
    270508 ALLODERM MESH, SURGICAL, POLYMERIC FTL ALLERGAN / LIFECELL
    270509 EXPANDER EXPANDER, SKIN, INFLATABLE LCJ ALLERGAN
    270510 EXPANDER EXPANDER, SKIN, INFLATABLE LCJ ALLERGAN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| S