BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DERMATHERAPY

    MDR report key: 7425294 · Received April 12, 2018

    Report

    Report Number
    0001527185-2018-00001
    Event Type
    Injury
    Date Received
    April 12, 2018
    Product Code
    FME
    PMA / PMN Number
    NONE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    GENERAL USE PATIENT GOWN. THE PRODUCT CODE LISTED IS NOT CORRECT. THIS DEVICE IS NOT CLASSIFIED AS A MEDICAL DEVICE. THIS IS A GENERAL USE PATIENT GOWN. THE INITIAL REPORTER IDENTIFIED THIS AS AN EXAMINATION GOWN INCORRECTLY. MODEL #749D6425, LOT #CDC010313880. OTHER - THE INFORMATION SUPPLIED ON THE GOWN'S USE DOES NOT MEET THE FDA CRITERIA FOR A REPORTABLE EVENT. THE PATIENT GOWN WAS NOT DIRECTLY IMPLICATED IN THE PATIENT BURN/BLISTERS, I.E., GOWN HAD NO CONTACT WITH AFFECTED AREA. THIS WAS CONFIRMED DURING FOLLOW-UP DISCUSSIONS WITH THE (6) HOSP. ON 2/14/2018 STANDARD TEXTILE'S VICE PRESIDENT OF QUALITY, SPOKE DIRECTLY WITH (B)(6), RISK MANAGEMENT SPECIALIST, AT (B)(6) HOSPITAL. SHE CONFIRMED THAT THE GOWN IN QUESTION CAME FROM A COMPLETED TRIAL FROM THE (B)(6) BURN UNIT AND THAT THE GOWNS WERE PROVIDED, NOT PURCHASED. WHEN THE TRIAL WAS COMPLETED, THE GOWNS WERE NOT RETURNED. MS. (B)(6) BELIEVES THAT THESE GOWNS WERE PUT INTO THEIR REGULAR LAUNDRY AND CIRCULATED WITH THE OTHER EXAMINATION GOWNS. SUBSEQUENTLY THIS PATIENT GOWN WAS USED ON THE MRI PATIENT THAT HAD THIS MEDICAL EVENT OCCUR. AS THIS GOWN HAS SNAPS/METAL CLOSURES ON THE TOP/NECK, THE MRI INSTRUCTION FOR USE PRECLUDE METAL FROM BEING USED DURING THE PROCEDURE. MS. OWENS DID CONFIRM THAT METAL SNAPS WOULD NOT BE APPROPRIATE FOR AN MRI PROCEDURE. IMPORTANT NOTE: THE SNAPS ON THE GOWN WERE NOT IN CLOSE PROXIMITY TO THE PATIENT BURN/BLISTERS AND THE UPPER BODY AREAS IN CONTACT WITH THE SNAPS WERE NOT ASSOCIATED WITH THE BURNS OR BLISTERING. NO ADVERSE EFFECTS WERE OBSERVED DUE TO THE USE OF THIS GOWN EVEN THOUGH GOWNS WITH METAL SNAPS SHOULD NOT BE USED IN MRI'S. OUR CONCLUSION IS THAT THE PATIENT GOWN WAS NOT INVOLVED WITH THE BURN/BLISTERING REPORTED BY THE PATIENT. - ATTACHMENT: (B)(4)

    Description of Event or Problem · 1

    HOSPITAL INDICATED THAT A PATIENT WITH RIGHT LEG EDEMA WAS UNDERGOING AN MRI AND INDICATED THAT SHE FELT SOMETHING DURING THE SCAN. THE SCAN WAS STOPPED AND THERE WERE TWO WELTS ON THE INSIDES OF HER THIGHS. THE PATIENT WANTED TO PROCEED WITH THE SCAN. AFTER THE SCAN WAS COMPLETE, BLISTERS APPEARED IN THE AREA OF THE WELTS. THE GOWN AND ROBE SHE WAS WEARING WAS NOT TOUCHING THE AREA WHERE THE BLISTERS AROSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    269596 DERMATHERAPY EXAMINATION, GOWN FME

    Patients

    Seq Age Sex Outcome Treatment
    1