BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTON SELF ADHERING FOAM

    MDR report key: 87799 · Received April 28, 1997

    Report

    Report Number
    2110898-1997-00011
    Event Type
    Injury
    Date Received
    April 28, 1997
    Date of Event
    November 26, 1996
    Report Date
    April 21, 1997
    Manufacturer
    3M MEDICAL PRODUCTS GROUP
    Product Code
    KGX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE SELF-ADHERING FOAM WAS APPLIED ON THIS PATIENT FOLLOWING LIPOSUCTION SURGERY. PATIENT REQUIRED REHOSPITALIZATION FOR TREATMENT OF CELLULITIS. PHYSICIANS INDICATED THAT PATIENT EXPERIENCED AN ALLERGIC REACTION TO THIS PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTON SELF ADHERING FOAM CUSHIONING, PAD KGX 3M MEDICAL PRODUCTS GROUP UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Life Threatening| R