BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENSE XL TORSO COIL 3, OT

    MDR report key: 4448176 · Received January 20, 2015

    Report

    Report Number
    1056069-2015-00002
    Event Type
    Injury
    Date Received
    January 20, 2015
    Date of Event
    November 25, 2014
    Report Date
    January 20, 2015
    Manufacturer
    INVIVO CORP
    Product Code
    LNH
    PMA / PMN Number
    K043147
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD, RESULTS, CONCLUSION: THE INVESTIGATION IS STILL ONGOING ON THIS EVENT. WHEN THE INVESTIGATION IS COMPLETED A FOLLOW UP REPORT WILL BE SENT TO THE FDA.

    Additional Manufacturer Narrative · 1

    (B)(4). BASED ON THE PROVIDED INFORMATION SITE THERE IS NO INDICATION OF A MALFUNCTION OF THE MR SYSTEM OR COIL INVOLVED.NO DEFINITE CAUSE FOR THE INJURY ON THE BELLY OF THE PATIENT COULD BE DETERMINED.THE TORSO XL THAT WAS USED FOR THIS EXAMINATION CONSISTS OF TWO PARTS, ONE ELEMENT IS PLACED POSTERIOR TO THE PATIENT AND ONE ON TOP (ANTERIOR) OF THE PATIENT.THE CABLES OF THE TWO COIL ELEMENTS EXIT ON THE SIDE. THEREFORE IT CAN BE CONCLUDED THAT THERE WAS NO CABLE OF THE COIL IN THE VICINITY OF THE BELLY BUTTON.THE COIL ELEMENT ITSELF IS SEPARATED FROM THE PATIENT BY A COIL CUSHION.CONTRIBUTING FACTORS TO THE INJURY ARE THE USED SCAN PROTOCOLS WITH SEVERAL SCANS ON HIGH SAR AND AN APPLIED SED OF 4836 J/KG AND THE MEDICAL CONDITION OF THE PATIENT

    Description of Event or Problem · 1

    A FEMALE PT WAS POSITIONED FEET FIRST SUPINE, WITH THE TORSO XL COIL AROUND THE BELLY FOR AN EXAMINATION OF THE CERVIX. AFTER THE EXAMINATION A BLISTER OF 2 CM IN DIAMETER WAS OBSERVED AROUND THE BELLY BUTTON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    46939 SENSE XL TORSO COIL 3, OT NONE LNH INVIVO CORP 4535-673-94943

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Other