BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOCLUSIVE TRANSPARENT DRESSING

    MDR report key: 2651243 · Received August 7, 2009

    Report

    Report Number
    3007663067-2009-00005
    Event Type
    Injury
    Date Received
    August 7, 2009
    Date of Event
    July 3, 2009
    Report Date
    July 9, 2009
    Manufacturer
    SYSTAGENIX WOUND MANAGEMENT MANUFACTURING LIMITED
    Product Code
    FRO
    PMA / PMN Number
    K895207
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. A REVIEW OF THE BATCH MFG RECORDS WAS CONDUCTED. THE REVIEW DID NOT IDENTIFY ANY NON-CONFORMANCES AND THE BATCH MET ALL RAW MATERIAL, IN-PROCESS AND FINISHED GOODS RELEASE CRITERIA. SHOULD ADD'L INFO BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY. THIS IS ONE OF TWO MEDWATCHES BEING SUBMITTED AS TWO DEVICES WERE INVOLVED IN THIS EVENT. SEE ALSO MEDWATCH 3007663067-2009-00004. THE SAME PT IS REPRESENTED IN EACH MEDWATCH.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TRANSPARENT DRESSING WAS APPLIED TO A CENTRAL LINE CATHETER INSERTION SITE ON AN UNK DATE. THE LENGTH OF TIME THE DRESSING WAS IN PLACE IS UNK. ON (B)(6) 2009, THE NURSE OBSERVED NO ADHERENCE OF THE DRESSING AND A POSSIBLE INFECTION AT THE CENTRAL LINE CATHETER INSERTION SITE. THE CENTRAL LINE CATHETER WAS CHANGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOCLUSIVE TRANSPARENT DRESSING DRESSING FRO SYSTAGENIX WOUND MANAGEMENT MANUFACTURING LIMITED NA 0834

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention