BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BLOM-SINGER NASAL SEPTAL PERFORATION PROSTHESIS

    MDR report key: 8931263 · Received August 26, 2019

    Report

    Report Number
    MW5089311
    Event Type
    Injury
    Date Received
    August 26, 2019
    Date of Event
    August 6, 2019
    Report Date
    August 21, 2019
    Manufacturer
    INHEALTH TECHNOLOGIES / FREUDENBERG MEDICAL, LLC
    Product Code
    LFB
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A (B)(6) Y/O FEMALE WAS ADMITTED ON (B)(6) 2019 DUE TO OSTEOMYELITIS OF HER RIGHT BIG TOE SECONDARY TO AN INFECTED ULCER. PODIATRIST DOCUMENTED ON (B)(6) 2019 HE BELIEVED AN MRI WAS NECESSARY FOR DEVELOPING PLAN OF CARE FOR THIS PT. MRI ORDER WAS PLACED BY HOSPITALIST AT 12:41 PM ON (B)(6) 2019. PT'S MRI WAS PERFORMED ON (B)(6) 2019 AT 20:00. ON (B)(6) 2019, HOSPITALIST DOCUMENTED "ENT CONSULTATION REQUESTED, MRI MAY HAVE DISLODGED SEPTAL BUTTON (THROUGH OUT OF FIELD)". ENT CONSULT OCCURRED ON (B)(6) 2019, ENT PROVIDER NOTED PT COMPLAINED THAT NASAL BUTTON WAS DISLODGED DURING THE MRI ON (B)(6) 2019. PER THE MEDICAL RECORD, PT DENIED ASPIRATION, CHOKING, OR EPISTAXIS. ENT PROVIDER DOCUMENTED NASAL BUTTON WAS REMOVED WITHOUT DIFFICULTY FROM LEFT NARES AND RECOMMENDED F/U IN THE OUTPATIENT SETTING. NOTIFICATION OF POSSIBLE EVENT REGARDING MRI OCCURRED ON (B)(6) 2019. AFTER FURTHER INVESTIGATION, IT WAS DETERMINED THE PT HAD A NASAL SEPTAL PERFORATION PROSTHESIS PLACED ON (B)(6) 2019. ON (B)(6) 2019 THE VENDOR CONFIRMED THE DEVICE PLACED "SHOULD NOT BE IN SITU DURING MRI EXAMINATION." FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    727108 BLOM-SINGER NASAL SEPTAL PERFORATION PROSTHESIS NASAL SEPTAL BUTTON LFB INHEALTH TECHNOLOGIES / FREUDENBERG MEDICAL, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other