BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCRUB PANTS/LARGE

    MDR report key: 7011158 · Received November 8, 2017

    Report

    Report Number
    3011270181-2017-00009
    Event Type
    Injury
    Date Received
    November 8, 2017
    Date of Event
    September 13, 2017
    Report Date
    December 7, 2017
    Manufacturer
    HALYARD HEALTH
    Product Code
    LYU
    UDI-DI
    30680651697029
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAFETY INFORMATION OF THE FABRIC WAS REVIEWED, THE TEST RESULTS DON'T INDICATE A POTENTIAL FOR DERMAL IRRITATION OR SENSITIZATION. THE SCRUB SUIT INVOLVED IN THIS EVENT IS NOT RECOMMENDED FOR THE APPLICATION OF MRI. SCRUBS ARE NORMALLY WORN BY HEALTH CARE PERSONNEL. HOWEVER, GIVEN THE SCRUB IS MADE OF THE SAME POLYPROPYLENE FABRIC AS THE EXAM GOWNS, THERE IS NO KNOWN CONNECTION BETWEEN THE SCRUB AND THIS INJURY. ALL INFORMATION REASONABLY KNOWN AS OF 15 DEC 2017 HAS BEEN INCLUDED IN THIS HEALTH AUTHORITY REPORT. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A FOLLOW-UP HEALTH AUTHORITY REPORT WILL BE PROVIDED. THE INFORMATION PROVIDED BY HALYARD HEALTH 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 HALYARD HEALTH. HALYARD HEALTH HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE HALYARD HEALTH COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4).

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORD IS IN-PROGRESS. THE ACTUAL COMPLAINT PRODUCT WAS NOT RETURNED FOR EVALUATION. ROOT CAUSE COULD NOT BE DETERMINED. ALL INFORMATION REASONABLY KNOWN AS OF 8-NOV-17 HAS BEEN INCLUDED IN THIS HEALTH AUTHORITY REPORT. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A FOLLOW-UP HEALTH AUTHORITY REPORT WILL BE PROVIDED. THE INFORMATION PROVIDED BY HALYARD HEALTH 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 HALYARD HEALTH. HALYARD HEALTH HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE HALYARD HEALTH COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN MRI SCAN WHILE WEARING DISPOSABLE SCRUB PANTS. IT WAS ALLEGED THAT THE PATIENT SUSTAINED SKIN BURNS ON THE HIPS AND LEGS DURING THE MRI. PER ADDITIONAL INFORMATION RECEIVED 8 NOV 2017, THE MRI SCAN WAS OF THE CERVICAL SPINE. THE PATIENT'S SKIN AND THE MATERIAL OF THE SCRUB PANTS BECAME SCORCHED. THE PATIENT WAS BURNED ON THE INNER SIDE OF THE RIGHT BREAST. NO FURTHER INFORMATION HAS BEEN PROVIDED TO HALYARD AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    789431 SCRUB PANTS/LARGE SCRUB PANTS LYU HALYARD HEALTH 991069702 CA5067006 30680651697029

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other