BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHONAK SKY L-UP

    MDR report key: 21676661 · Received March 24, 2025

    Report

    Report Number
    3005085999-2025-00006
    Event Type
    Injury
    Date Received
    March 24, 2025
    Date of Event
    March 17, 2025
    Report Date
    March 20, 2025
    Manufacturer
    SONOVA AG
    Product Code
    OSM
    UDI-DI
    07613389633559
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER HAS INITIATED THE INVESTIGATION AND FOLLOW UP WITH THE HCP TO CLARIFY THE CIRCUMSTANCES OF THE INCIDENT. THE ACCOMPANYING USER GUIDE CONTAINS INSTRUCTIONS ABOUT THE CORRECT USE OF TAMPER-PROOF BATTERY DOOR AND HAZARD WARNINGS ABOUT THE DANGER OF SWALLOWING A BATTERY AND OTHER SMALL AND DETACHABLE PARTS, TO KEEP THE DEVICE OUT OF REACH OF CHILDREN AND IF SWALLOWED TO CONSULT A PHYSICIAN IMMEDIATELY. THE DEVICE COMPLIES WITH IEC 60601-1-11 §8.5.2 REQUIREMENT. THE RISK FILE HAS ALREADY CONSIDERED AND INCLUDES A RISK ADDRESSING POSSIBILITY OF SWALLOWING A BATTERY. THE INVESTIGATION IS ONGOING. THE MANUFACTURER WILL SUBMIT A FOLLOW UP REPORT UPON AVAILABILITY OF NEW INFORMATION. THIS CASE IS RELATED TO 3005085999-2025-00005.

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER CONDUCTED AN INVESTIGATION WHICH INCLUDED DEVICE ANALYSIS, FOLLOW UP INTERVIEWS WITH THE HCP, LABELLING AND OTHER DOCUMENTATION REVIEW, AND REVIEW OF SIMILAR COMPLAINTS. DEVICE ANALYSIS SHOWED EXISTING DAMAGE TO THE HEARING AID HOUSING, PARTICULARLY AROUND THE DOOR AREA AND TO THE LOCKING MECHANISM. THERE WAS A FATIGUE FRACTURE (A CRACK) OBSERVED INSIDE THE BATTERY DOOR THAT COULD PROPAGATE UNDER SMALL AND REPEATED LOADS. DUE TO THIS THE MATERIAL MAY LOSE STIFFNESS AND CAN DEFORM, POTENTIALLY REDUCING THE LOCKING MECHANISM. THE WEAR PATTERNS AT THE EDGE OF HOUSING INDICATE UNUSUAL SCRATCH MARKINGS OBSERVED ON THE HOUSING AND DOOR INTERFACE. SUCH PATTERNS SHOULD NOT OCCUR IF THE DEVICE IS OPENED USING THE DESIGNATED BATTERY DOOR OPENING TOOL. FREQUENT OPENING OF THE BATTERY DOOR USING ALTERNATIVE METHODS, RATHER THAN THE DEDICATED TOOL, IS NOT INTENDED AND CAN DAMAGE THE DEVICE. THE ACCOMPANYING USER GUIDE CONTAINS INSTRUCTIONS ABOUT THE CORRECT USE OF THE HEARING AID AND TAMPER-PROOF BATTERY DOOR SUCH AS HOW TO CORRECTLY OPEN AND CLOSE THE BATTERY DOOR, TO USE ONLY CORRECT BATTERY TYPE, TO AVOID MECHANICAL STRESS TO HEARING AIDS AND TO INSPECT THE HEARING AIDS BEFORE USE IF MECHANICAL SHOCK OCCURRED. THE USER GUIDE ALSO CONTAINS HAZARD WARNINGS ABOUT THE DANGER OF SWALLOWING A BATTERY AND OTHER SMALL AND DETACHABLE PARTS, TO KEEP THE DEVICE OUT OF REACH OF CHILDREN AND IF SWALLOWED TO CONSULT A PHYSICIAN IMMEDIATELY. THE REVIEW OF THE RISK FILE CONFIRMED THAT RISKS ADDRESSING POSSIBILITY OF SWALLOWING A BATTERY HAVE ALREADY BEEN ALREADY CONSIDERED. THE REVIEW OF APPLICABLE REQUIREMENTS AND TESTS CONFIRMED THAT THE DEVICE COMPLIES WITH IEC 60601-1-11 AND SPECIFICALLY §8.5.2. THE MANUFACTURER CHECKED INTERNAL COMPLAINT DATABASE FOR SIMILAR INCIDENTS IN THE PAST 5 YEARS. THERE WERE NO OTHER CASES RECORDED RELATING TO SWALLOWING BATTERIES FROM PHONAK SKY L OR OTHER SIMILAR DEVICES INTENDED FOR USE IN CHILDREN BELOW 36 MONTHS. THE MANUFACTURER IS MONITORING FOR TRENDS AND NO TRENDS WITH PAEDIATRIC DEVICES OR TAMPER PROOF DOOR HAVE BEEN RECORDED TO DATE. THE MANUFACTURER WILL KEEP MONITORING FOR TRENDS. THIS CASE IS RELATED TO 3005085999-2025-00005.

    Description of Event or Problem · 0

    THE PATIENT IS AN 18-MONTH-OLD GIRL WHO WAS USING PHONAK SKY L90-UP HEARING AIDS WITH TAMPER-PROOF BATTERY DOORS AND ZINC-AIR BATTERY. IT HAS BEEN REPORTED TO THE MANUFACTURER THAT THE PATIENT HAS MANAGED TO OPEN THE BATTERY DOOR AND SWALLOWED A SINGLE BUTTON CELL BATTERY ON TWO SEPARATE OCCASIONS ((B)(6) 2025 AND (B)(6) 2025). BOTH TIMES A SINGLE BATTERY WAS IDENTIFIED ON THE X-RAY IN THE PATIENT'S STOMACH. DURING THE SECOND INCIDENT, ONE BATTERY WAS INGESTED BUT THE OTHER WAS FOUND IN HER MOUTH BEFORE IT COULD BE INGESTED. THE BATTERIES EXITED PATIENT'S SYSTEM AND THE PATIENT DID NOT EXPERIENCE ANY HARM DUE TO THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    740085 PHONAK SKY L-UP BEHIND-THE-EAR-AIR-CONDUCTION HEARING AID OSM SONOVA AG 0501082T3 07613389633559

    Patients

    Seq Age Sex Outcome Treatment
    1 18 MO Female Other PHONAK SKY L-UP (B)(4)