BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GN RESOUND

    MDR report key: 14431559 · Received May 18, 2022

    Report

    Report Number
    3005650109-2022-00003
    Event Type
    Injury
    Date Received
    May 18, 2022
    Report Date
    June 22, 2022
    Manufacturer
    GN HEARING A/S
    Product Code
    OSM
    UDI-DI
    05708296140800
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4): CASE REPORTED IN (B)(6). THIS HAS BEEN REPORTED TO (B)(6) AUTHORITIES. THIS IS A COMBINED REPORT- INTIAL AND FOLLOW UP. INVESTIGATION HAS BEEN COMPLETED. ROOT CAUSE: NO ABNORMITY FOUND ABOUT MFG PROCESS BASED ON SAMPLES INVESTIGATION, ALL MANUFACTURING RECORDS AND POTENTIAL FAILURE MODES REVIEW (DHR, UV CURING, THICKNESS, ETC.) . MORE RELATED TO RELIABILITY ISSUE BASED ON CUSTOMER USAGE FOR A WHILE (2 YEARS).

    Additional Manufacturer Narrative · 0

    SF (B)(6) . CASE REPORTED IN CHINA. THIS HAS BEEN REPORTED TO CHINESE AUTHORITIES. THIS IS A COMBINED REPORT- INTIAL AND FOLLOW UP. INVESTIGATION HAS BEEN COMPLETED. ROOT CAUSE: NO ABNORMITY FOUND ABOUT MFG PROCESS BASED ON SAMPLES INVESTIGATION, ALL MANUFACTURING RECORDS AND POTENTIAL FAILURE MODES REVIEW (DHR, UV CURING, THICKNESS, ETC.) . MORE RELATED TO RELIABILITY ISSUE BASED ON CUSTOMER USAGE FOR A WHILE (2 YEARS). 22-JUN-2022: NATIONAL MEDICAL PRODUCT ADMINISTRATION IN CHINA REQUESTED RESULTS OF THE INVESTIGATION OF THE DEVICE TRANSLATED TO CHINESE. THE TRANSLATION WAS PROVIDED ON 22-JUN-2022. NO OTHER UPDATES TO REPORT.

    Description of Event or Problem · 0

    (B)(4)-ENCASED MICRO-MOLD,3 PIN,MP(B)(4) DURING NORMAL WEARING, THE SHELL IS SUDDENLY BROKEN AND THE EXTERNAL EAR SCRATCH. THE DEVICE BROKE WHEN USING AT HOME. THE OBJECT WAS REMOVED BY THE USER AND CAUSED BLEEDING. THE USER HAS NOT EXPERIENCED THIS BEFORE. THE USER HAS BEEN IN CONTACT WITH A MEDICAL PRACTIONER AND NO TREATMENT WAS GIVEN. THE MEDICAL PRACTIONER COMMENTED- THE EAR LOOKS NOT SO SERIOUS AND REMEMBER NOT TO TOUCH WATER.

    Description of Event or Problem · 0

    XU ZIXIAO 19709500-ENCASED MICRO-MOLD,3 PIN,MP(B)(6). DURING NORMAL WEARING, THE SHELL IS SUDDENLY BROKEN AND THE EXTERNAL EAR SCRATCH. THE DEVICE BROKE WHEN USING AT HOME. THE OBJECT WAS REMOVED BY THE USER AND CAUSED BLEEDING. THE USER HAS NOT EXPERIENCED THIS BEFORE. THE USER HAS BEEN IN CONTACT WITH A MEDICAL PRACTIONER AND NO TREATMENT WAS GIVEN. THE MEDICAL PRACTIONER COMMENTED- THE EAR LOOKS NOT SO SERIOUS AND REMEMBER NOT TO TOUCH WATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2606146 GN RESOUND HEARING AID OSM GN HEARING A/S EM,NC-HA-RF1-MP3P 05708296140800

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other