BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GRANUFLEX/DUOACTIVE MOISTURE RETENTIVE DRSG

    MDR report key: 4101112 · Received September 17, 2014

    Report

    Report Number
    1049092-2014-00489
    Event Type
    Injury
    Date Received
    September 17, 2014
    Date of Event
    August 22, 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

    BASED ON THE AVAILABLE INFO, THIS EVENT IS DEEMED TO BE A SERIOUS INJURY. PER THE INFO RECEIVED, THE DEVICE WAS REMOVED SEVERAL DAYS AFTER THE APPLICATION. NO ADDITIONAL INFO HAS BEEN PROVIDED TO DATE. SHOULD ADDITIONAL INFO BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. REPORTED TO FDA ON (B)(4) 2014.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED ON AUGUST 13, 2015 CONFIRMING THAT 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).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE END USER HAD A WOUND TO THE SACRUM. AFTER CLEANING THE WOUND, A DRESSING WAS APPLIED. THE DRESSING WAS CHANGED AFTER A FEW DAYS IN WHICH A RED PLACE WAS OBSERVED UNDER THE ENTIRE DRESSING. PER THE REPORT, THE DRESSING ADHERES TO THE SKIN. THE FIRST DAY AFTER THE REMOVAL OF THE DRESSING, DERMABRASION WAS APPLIED OVER THE DAMAGED BURNED SKIN AREA. BIAFINE WAS APPLIED TO THE BURNED SKIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    576699 GRANUFLEX/DUOACTIVE MOISTURE RETENTIVE DRSG NAD CONVATEC INC 187632 CNO

    Patients

    Seq Age Sex Outcome Treatment
    1 93 YR Required Intervention