MAUDE Adverse Event Report: PHONAK AG PHONAK AUDÉO B90-R; ITE HEARING AID, PRODUCT CODE: OSM

Model Number	050-0237-P5
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No deviation in device production process has been identified.The device analysis was not performed because the reportable information was unknown at the time of repair.The customer receives a free-of-charge replacement of the faulty cshell earpiece.Reported adverse event known and documented in the labeling.
Event or Problem Description
The patient has been using phonak audéo b90-r hearing aid with a custom cshell earpiece.Cerustop bushing of the earpiece got disengaged from the cshell while in use and remained in the patient's ear.The patient required medical intervention under general anesthesia to remove the part from the ear.General anesthesia was required due to the fact that the part was located too close to the eardrum in the ear canal.The patient did not suffer any injury as the result of this event.The patient has successfully recovered from the intervention and resumed the use of the device.

• Brand Name: PHONAK AUDÉO B90-R
• Common Device Name: ITE HEARING AID, PRODUCT CODE: OSM
• Manufacturer (Section D): PHONAK AG; laubisrütistrasse 28; stäfa, zurich, che 8712 ; SZ 8712
• Manufacturer Contact: minal maurya ; 750 n commons dr.; aurora, IL 60504 ; 6308219589
• MDR Report Key: 14218880
• Report Number: 3005085999-2021-00002
• Device Sequence Number: 4208266
• Product Code: OSM
• UDI-Device Identifier: 07613275475881
• UDI-Public: 07613275475881
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Repair
• Type of Report: Initial
• Report Date (Section B): 08/13/2021

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?: No
• Operator of Device: Lay User/Patient
• Device Model Number: 050-0237-P5
• Device Catalogue Number: 050-0237-P5
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/12/2018
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 77 YR
• Patient Sex: Female