MAUDE Adverse Event Report: FP962-DRW,FLYTE 990,GN HEARING; HEARING AID, AIR CONDUCTION WITH WIRELESS TECHNOLOGY

Model Number	HI,FP962-DRW,STRL GRY
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	03/30/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Gn hearing a/s has become aware that this mdr report failed submission to fda without our notice.The fda help desk has advised to re-submit the reports.This is a re-submission of existing mdr initial submitted on 28apr2021.Manufacturers ref# (b)(4).This case has been determined to be reportable as it was reported that the dome fell off hearing aid and burrowed into the patients ear.It took around 90 minutes for doctor to get the dome out of his ear.During extraction, the doctor scratched the ear canal and the patient began to bleed and had to get a prescription for vitamin k to quell the bleeding as he is undergoing leukemia treatment.Based on above the event is considered reportable in us as a serious injury requiring medical intervention.Summary of investigation findings: the case has been reviewed from a clinical perspective.Clinical evaluation of the event: case information states that the dome had to be removed by a medical professional.No other treatment was performed, but vitamin k was prescribed in order to stop the bleeding.The main contributing factor to a loose dome is if it is not properly attached to the hearing instrument.As already considered in this case it could be recommended that the end user tries out custom moulds instead of domes.According to #0271620 dec.Tree guide pot.Safety rel., removal of dome is not defined as medical intervention.However, as vitamin k was prescribed to stop the bleeding that was caused by the loose dome, clinical conclusion on the case is that the event required medical intervention.Clinical evaluation according to 0378040 clin eval plan&rpt,ha&tsg and 0378100 clin eval plan&rpt,other acc: the clinical evaluation for the device family does evaluate domes coming loose in the ear canal.This is identified in the risk analysis and mitigated through device design by ensuring a sufficient pull force (compliance with iec 60601-2-66) to reduce the risk of domes coming loose in the ear canal as far as possible.The main contributing factor to a loose dome is if it is not properly attached to the hearing instrument.The user guide includes instructions in how to mount a dome correctly, mitigating the risk of dome detachment.Furthermore, the user guide states to contact the hcp if a foreign object or wax is located in the ear canal to reduce the potential risk of harm as far as possible.There are no new clinical aspects (e.G.Unforeseen use or clinical conditions) discovered from this event.Therefore, it is concluded that the current clinical evaluation and risk/benefit conclusions herein are sufficient.Device manufactured accepted to specifications, all inspections passed and no deviations/changes implemented during the production.This case is considered as a single incident and will be included in regular trending.No actions have been initiated based on this individual event.
Event or Problem Description
Description of event from initial reporter: patient had to seek medical care because dome became lodged too deeply in ear.During extraction, patient began to bleed from his ear and had to get a prescription for vitamin k to quell the bleeding as he is undergoing leukemia treatment.According to questionnaire: patient realized sunday morning that something was wrong in his ear.He and his wife attempted to locate dome but could not.Made appointment for doctor visit on monday afternoon so his regular doctor could look at it.It took around 90 minutes for her to get the dome out of his ear.During extraction, the doctor scratched the ear canal and the patient began to bleed and had to get a prescription for vitamin k to quell the bleeding as he is undergoing leukemia treatment.Ear is still sore.Patient is nervous about replacing his dome and continuing to wear the hearing aids.

• Brand Name: FP962-DRW,FLYTE 990,GN HEARING
• Common Device Name: HEARING AID, AIR CONDUCTION WITH WIRELESS TECHNOLOGY
• MDR Report Key: 12504565
• Report Number: 3005650109-2021-00006
• Device Sequence Number: 14430311
• Product Code: OSM
• UDI-Device Identifier: 05708296094189
• UDI-Public: 05708296094189
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: HI,FP962-DRW,STRL GRY
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/30/2021
• Initial Report FDA Received Date: 09/21/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/30/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention