BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIFLO INDWELLING BOWEL CATHETER SYSTEM

    MDR report key: 1611845 · Received February 12, 2010

    Report

    Report Number
    1480288-2010-00001
    Event Type
    Injury
    Date Received
    February 12, 2010
    Report Date
    February 12, 2010
    Manufacturer
    HOLLISTER, INC.
    Product Code
    MIP
    PMA / PMN Number
    K083153
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). NO ADD'L INFO WAS PROVIDED. IT WAS REPORTED THAT THE ANCHOR STRAPS WERE LEFT UNSECURED CONTRARY TO THE INSTRUCTIONS FOR USE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT WAS ADMITTED TO THE HOSP WITH A PRE-EXISTING POSTERIOR ANUS PRESSURE ULCER AS WELL AS AN OPEN LUMBAR WOUND. THE PT REPORTEDLY SUFFERED FROM VARIOUS OTHER COMORBIDITIES. THE ACTIFLO INDWELLING BOWEL CATHETER WAS PLACED IN THE PT TO HELP DURING THE HEALING PROCESS OF THE PRE-EXISTING WOUNDS. THE PT DEVELOPED A 3CM WIDE FULL THICKNESS PRESSURE INJURY IN THE AREA OF THE ANTERIOR ANUS. IT WAS REPORTED THAT THE ACTIFLO INDWELLING BOWEL CATHETER STRAPS WERE NOT BEING USED AND WERE NOT TAPED DOWN TO THE CATHETER - THEREFORE, FLOATING FREELY AND POTENTIALLY RUBBING AGAINST THE SKIN. IT WAS REPORTED THAT THE CATHETER HAD TWISTED, MIGRATED AND THE FACEPLATE WAS RUBBING AGAINST THE ANUS. IT WAS ALSO REPORTED THAT A PRESSURE ULCER MAY HAVE BEEN CAUSED FROM THE PT LYING ON THE TRIPLE LUMEN OF THE CATHETER. THE PT WAS TAKEN TO THE OPERATING ROOM FOR DEBRIDEMENT ON THE 2 PRE-EXISTING WOUNDS AND WHILE THERE, THE THIRD WAS ALSO DEBRIDED AS WELL. THE ULCER WAS REPORTED TO BE HEALING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACTIFLO INDWELLING BOWEL CATHETER SYSTEM ACTIFLO RECTAL CATHETER MIP HOLLISTER, INC. 32006

    Patients

    Seq Age Sex Outcome Treatment
    1 Other