BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GRANUFLEX/DUOACTIVE MOISTURE RETENTIVE DRSG

    MDR report key: 4101102 · Received September 17, 2014

    Report

    Report Number
    1049092-2014-00490
    Event Type
    Injury
    Date Received
    September 17, 2014
    Date of Event
    August 20, 2014
    Report Date
    August 29, 2014
    Manufacturer
    CONVATEC, INC.
    Product Code
    NAD
    PMA / PMN Number
    K881050
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED ON AUGUST 13, 2015 CONFIRMING THE LOT NUMBER IS INVALID. HAS BEEN UPDATED TO REFLECT THE APPLICABLE INFORMATION. NO ADDITIONAL PATIENT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE A FOLLOW-UP REPORT WILL BE SUBMITTED. (B)(4).

    Additional Manufacturer Narrative · 1

    BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A SERIOUS INJURY. PER THE INFORMATION RECEIVED, THE DEVICE WAS DISCONTINUED. BASELINE IS CURRENTLY USED AS A DRESSING. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED TO DATE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. REPORTED TO THE FDA ON (B)(4) 2014.

    Description of Event or Problem · 1

    IT WAS REPORTED THE END USER HAD A DRESSING APPLIED AFTER CLEANING THE WOUND WITH PHYSIOLOGICAL SERUM. IT WAS FURTHER REPORTED THE DRESSING STICKS TO THE SKIN AND TWISTS ITSELF. THE REMOVAL IS PAINFUL AND THERE ARE STILL PIECES ON THE SKIN AND THE NURSE HAS TO SCRATCH IN ORDER TO REMOVE THE PIECES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    576302 GRANUFLEX/DUOACTIVE MOISTURE RETENTIVE DRSG OCCULUSIVE WOUND DRESSING, 79NAD NAD CONVATEC, INC. 187632 CNO

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention