BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ABTHERA ABDOMINAL THERAPY SYSTEM

    MDR report key: 2000825 · Received February 17, 2011

    Report

    Report Number
    1625774-2011-00023
    Event Type
    Injury
    Date Received
    February 17, 2011
    Date of Event
    January 1, 2010
    Report Date
    January 20, 2011
    Manufacturer
    KCI USA, INC.
    Product Code
    OMP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE UNIT WAS TESTED PER QUALITY CONTROL (QC) PROCEDURES BY A KCI FIELD SERVICE ASSOCIATE ON (B)(6) 2010, PRIOR TO PLACEMENT WITH THE PT. THE UNIT PASSED THE QC CHECKS AND MET SPECS. THE UNIT REMAINED WITH THE CUSTOMER UNTIL THE THERAPY DISCHARGE DATE OF (B)(6) 2010. DEVICE LABELING, AVAILABLE IN PRINT AND ONLINE, STATES CONTRAINDICATIONS: PROTECT VITAL STRUCTURES WITH ABTHERA VISCERAL PROTECTIVE LAYER AT ALL TIMES DURING THERAPY. NEVER PLACE EXPOSED FOAM MATERIAL DIRECTLY IN CONTACT WITH EXPOSED BOWEL, ORGANS, BLOOD VESSELS OR NERVES.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE DOCTOR ALLEGED THAT THE ABTHERA CAUSED A FISTULA DUE TO THE BLUE FOAM TOUCHING THE BOWEL. NO FURTHER INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABTHERA ABDOMINAL THERAPY SYSTEM OMP KCI USA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other