BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OTOVENT

    MDR report key: 6352553 · Received February 23, 2017

    Report

    Report Number
    8043991-2017-00001
    Event Type
    Injury
    Date Received
    February 23, 2017
    Date of Event
    January 6, 2017
    Report Date
    February 21, 2017
    Manufacturer
    ABIGO MEDICAL AB
    Product Code
    MJV
    PMA / PMN Number
    K920840
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT REPORTED TO HAVE A MEDICAL HISTORY OF PREVIOUS ACUTE OTITIS MEDIA WITH PERFORATION OF THE EAR DRUM, LONGSTANDING SEROUS OTITIS MEDIA TREATED WITH GROMMETS AND THE REOCCURRENCE OF NEW SEROUS OTITIS MEDIA. DUE TO EARLIER PERFORATIONS OF THE EAR DRUM AND TREATMENT WITH GROMMETS REPORTED, THE PATIENT MAY BE CONSIDERED AT GREATER RISK OF PERFORATIONS. THE CASE IS CONSIDERED TO BE OF MINOR TO MODERATE SEVERITY THAT COULD RESULT IN INJURY OR IMPAIRMENT POSSIBLY REQUIRING PROFESSIONAL MEDICAL INTERVENTION.

    Additional Manufacturer Narrative · 1

    PATIENT REPORTED TO HAVE A MEDICAL HISTORY OF PREVIOUS ACUTE OTITIS MEDIA WITH PERFORATION OF THE EAR DRUM, LONGSTANDING SEROUS OTITIS MEDIA TREATED WITH GROMMETS AND THE REOCCURRENCE OF NEW SEROUS OTITIS MEDIA. DUE TO EARLIER PERFORATIONS OF THE EAR DRUM AND TREATMENT WITH GROMMETS REPORTED, THE PATIENT MAY BE CONSIDERED AT GREATER RISK OF PERFORATIONS. THE CASE IS CONSIDERED TO BE OF MINOR TO MODERATE SEVERITY THAT COULD RESULT IN INJURY OR IMPAIRMENT POSSIBLY REQUIRING PROFESSIONAL MEDICAL INTERVENTION. ADDITIONAL INFORMATION IN FOLLOW UP REPORT: THE PATIENT HAS BEEN REPORTED VIA PROFESSIONAL HEALTHCARE TO BE RECOVERED.

    Description of Event or Problem · 1

    THE DEVICE HAD BEEN USED AS DIRECTED FOR ABOUT 3-4 DAYS, WHEN THE USER DID ABOUT 2 PUFFS AND SUDDENLY CRIED OUT IN PAIN AND HOLDING HIS RIGHT EAR. THE REPORTER STATES A SPECIALIST NURSE HAS CONCLUDED A PERFORATION OF THE RIGHT EARDRUM THROUGH OTOSCOPE INVESTIGATION.

    Description of Event or Problem · 1

    THE DEVICE HAD BEEN USED AS DIRECTED FOR ABOUT 3-4 DAYS, WHEN THE USER DID ABOUT 2 PUFFS AND SUDDENLY CRIED OUT IN PAIN AND HOLDING HIS RIGHT EAR. THE REPORTER STATES A SPECIALIST NURSE HAS CONCLUDED A PERFORATION OF THE RIGHT EARDRUM THROUGH OTOSCOPE INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135587 OTOVENT OTOVENT MJV ABIGO MEDICAL AB

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR Other