BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESOUND

    MDR report key: 9424927 · Received December 6, 2019

    Report

    Report Number
    3005650109-2019-00015
    Event Type
    Injury
    Date Received
    December 6, 2019
    Date of Event
    November 6, 2019
    Report Date
    December 6, 2019
    Manufacturer
    GN HEARING A/S
    Product Code
    OSM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED IN SPITE OF SEVERAL ATTEMPTS TO RETRIEVE THE INVOLVED DEVICE. DEVICE HISTORY AND REPAIR HISTORY CHECKED.

    Description of Event or Problem · 1

    ON 08 NOV 2019 IT COMES TO GNH AWARENESS THAT AN END-USER HAD AN ALLERGIC REACTION, SHOWING AS BLISTERING, OOZING AND INFLAMMATION, TO ONE OF OUR DEVICES AFTER IT HAS BEEN RETURNED FROM REPAIR. IT IS KNOWN THAT THE END-USER IS ALLERGIC TO ADHESIVES, AMONG OTHER THINGS. ON 11 NOV 2019 IT COMES TO OUR KNOWLEDGE THAT THE END-USER WILL SEE AN ENT AND WILL RESTART MEDICAMENT TREATMENT FROM FIRST TIME ALLERGIC REACTION. (OUR REF. (B)(4), (B)(6) 2019, WHERE IT WAS NOT MENTIONED ANYTHING ABOUT SEEING AN ENT OR MEDICATION, HENCE NO MDR REPORTING). AS PER TODAY WE HAVEN'T RECEIVED ANY PICTURES OF THE ALLERGIC REACTION, NEITHER RECEIVED THE DEVICE FOR INVESTIGATION DESPITE SEVERAL ATTEMPTS. THE HCP REQUESTS A MATERIAL AND BUILD REPORTS FOR THE DEVICE, PRIOR RETURNING THE DEVICE TO GNH FOR INVESTIGATION. GNH HAS FROM THE HCP REQUESTED A LIST, OF MATERIALS THAT THE END-USER IS ALLERGIC TO CHECK GNH MATERIALS AGAINST. THIS IS PER TODAY NOT RECEIVED. AND FURTHER GNH HAS INFORMED THE HCP THAT REGARDING THE DIFFERENCES OF THE ORIGINAL DEVICE VERSUS THE ONE RETURNED FROM REPAIR; WE CANNOT CONFIRM WITH CERTAINTY WHAT THE CAUSE OF THE END-USER'S REACTION WAS UNTIL WE ARE ABLE TO CONDUCT THE PROPER TESTING OF THE DEVICE. GNH DO NOT MANUFACTURE OUR DEVICES IN A CLEAN ROOM, NOR DO WE HAVE STERILE DEVICES OR PROCESS THEM ASEPTICALLY. HOWEVER, WE CAN DOCUMENT THE BIOCOMPATIBILITY. THE COMMUNICATION WITH THE HCP (END-USER) IS STILL ON-GOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1220612 RESOUND LINX2 OSM GN HEARING A/S LS5 ITE-DW HP

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention