BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADAPTIC NON-ADHERING DRESSING

    MDR report key: 1050171 · Received May 23, 2008

    Report

    Report Number
    2210968-2008-00367
    Event Type
    Injury
    Date Received
    May 23, 2008
    Date of Event
    April 16, 2008
    Report Date
    April 22, 2008
    Manufacturer
    ETHICON, INC.
    Product Code
    FRO
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFO BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT HAD A TRAUMATIC INJURY TO THE RIGHT ULNA AND RADIUS IN 2008. A FASCIOTOMY WAS COMPLETED ON THE SAME DAY. WHILE IN THE HOSP, WET TO DRY DRESSINGS WERE PERFORMED ON THE WOUND. THE PT WAS THEN DISCHARGED TO HOME ON THE FOLLOWING MONTH. WHILE AT HOME, THE PT'S FAMILY AND HOME CARE WAS PERFORMING THE DRESSING CHANGES. DURING THAT TIME, THE DRESSING WAS PLACED OVER AN EXPOSED TENDON. THE PT WAS SEEN AT THE REHABILITATION FACILITY ON THE NEXT MONTH. AT THAT TIME IT WAS NOTED THAT THE DRESSING HAD BEEN LEFT IN PLACE ON THE WOUND AND THAT TISSUE HAD NOW GRANULATED OVER THE PRODUCT. ONLY THE DRESSING EDGES WERE EXPOSED AND COULD BE VISUALIZED. NO SIGNS OF INFECTION WERE NOTED AT THE WOUND SITE. THE PT WAS RETURNED TO SURGERY AS A RESULT, AND THE DRESSING WAS REMOVED FROM THE WOUND AND DISCARDED. THE PT WAS THEN DISCHARGED TO HOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADAPTIC NON-ADHERING DRESSING NON-ADHERING DRESSING FRO ETHICON, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention