BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STATLOCK FOLEY STABILIZATION DEVICE

    MDR report key: 4911513 · Received July 10, 2015

    Report

    Report Number
    1018233-2015-00218
    Event Type
    Injury
    Date Received
    July 10, 2015
    Date of Event
    June 11, 2015
    Report Date
    September 9, 2016
    Manufacturer
    DAVOL SURGICAL INNOIVATIONS
    Product Code
    EYJ
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RECEIVED TWO PHOTOS OF THE PATIENT'S INJURY. THE ACTUAL DEVICE WAS NOT RETURNED FOR EVALUATION. THE COMPLAINT HAS BEEN CONFIRMED WITH AN UNKNOWN ROOT CAUSE. THE LOT NUMBER IS UNKNOWN THEREFORE THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. THE INSTRUCTIONS FOR USE STATE THE FOLLOWING: "DO NOT ALTER THE STATLOCK® DEVICE OR COMPONENTS. PROCEDURE MUST BE PERFORMED BY TRAINED PERSONNEL WITH KNOWLEDGE OF ANATOMICAL LANDMARKS, SAFE TECHNIQUE AND POTENTIAL COMPLICATIONS" CONTRAINDICATIONS: KNOWN TAPE OR ADHESIVE ALLERGIES, APPLICATION TECHNIQUE, PREP: PLACE FOLEY CATHETER INTO RETAINER. DIRECTIONAL ARROW SHOULD POINT TOWARDS CATHETER TIP, AND BALLOON INFLATION ARM SHOULD BE NEXT TO THE HINGE. CLOSE LID, BEING CAREFUL TO AVOID PINCHING THE CATHETER. IDENTIFY SECUREMENT SITE BY LAYING THE DEVICE RETAINER ON THE FRONT OF THE THIGH, LEAVING 2.5 CM OF CATHETER SLACK BETWEEN INSERTION SITE AND THE STATLOCK® DEVICE RETAINER. AFTER PLACING THE STATLOCK® STABILIZATION DEVICE OFF TO THE SIDE, CLEANSE AND DEGREASE THE SECUREMENT SITE WITH ALCOHOL PER HOSPITAL POLICY. LET SKIN DRY. APPLY SKIN PROTECTANT, IN DIRECTION OF HAIR GROWTH, TO AREA LARGER THAN SECUREMENT SITE. ALLOW TO DRY COMPLETELY (10-15 SECONDS). USING PERMANENT MARKER, WRITE INITIALS AND DATE OF APPLICATION ON THE STATLOCK® DEVICE ANCHOR PAD. NOTE: ALWAYS SECURE CATHETER INTO THE STATLOCK® DEVICE RETAINER BEFORE APPLYING ADHESIVE PAD ON SKIN. REMOVAL TECHNIQUE. DISENGAGE. OPEN RETAINER BY PRESSING RELEASE BUTTON WITH THUMB, THEN LIFT TO OPEN. REMOVE FOLEY CATHETER FROM THE STATLOCK® DEVICE. DISSOLVE WIPE THE EDGE OF THE PAD USING AT LEAST 5-6 ALCOHOL PADS UNTIL A CORNER LIFTS. THEN CONTINUE TO STROKE UNDERSURFACE OF PAD WITH ALCOHOL TO DISSOLVE ADHESIVE PAD AWAY FROM SKIN. THE CURRENT DFU INCLUDES INDICATIONS ON THE APPLICATION AND REMOVAL TO USE ALCOHOL." (B)(4). THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BARD.

    Additional Manufacturer Narrative · 1

    THIS INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BARD. THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BARD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT UPON REMOVAL OF THE STATLOCK DEVICE THE PATIENT'S SKIN TORE OFF. THE DEVICE WAS PLACED ON (B)(4) 2015 AND REMOVED ON (B)(4) 2015 BY A NURSE WHILE ADMITTED TO A HOSPITAL. THE PATIENT SUFFERED FROM CHILLS, FEVER AND SHAKING. THE PATIENT WENT TO A PHYSICIAN, WHICH TOOK A FEW CULTURES. THE PATIENT WAS THEN STARTED ON LEVOFLOXACIN. THE PATIENT HAS VASCULITIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    448922 STATLOCK FOLEY STABILIZATION DEVICE EYJ DAVOL SURGICAL INNOIVATIONS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention