BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOPATCH ANTIMOCROBIAL DRESSING

    MDR report key: 376295 · Received February 12, 2002

    Report

    Report Number
    2210968-2002-00102
    Event Type
    Injury
    Date Received
    February 12, 2002
    Date of Event
    December 26, 2001
    Report Date
    December 26, 2001
    Manufacturer
    INTEGRA LIFE SCIENCE
    Product Code
    FRO
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT LESS THAN 36 HOURS AFTER PLACEMENT, SEROSANGUINOUS DRAINAGE WAS OBSERVED ON THE DRESSING. IT WAS STATED THE DRESSING WAS REMOVED AFTER 48 HOURS AND THE SKIN WAS DESCRIBED AS "BURNED", WITH A FULL THICKNESS WOUND. IT WAS REPORTED THAT THE SITE HAD BEEN PREPPED WITH BETADINE PRIOR TO PLACING THE DRESSING. THE AREA WAS TREATED WITH TOPICAL ANTIBIOTIC OINTMENT ONLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOPATCH ANTIMOCROBIAL DRESSING DRESSING FRO INTEGRA LIFE SCIENCE NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention