MAUDE Adverse Event Report: ADVANCED BIONICS, LLC HIRES ULTRA IMPLANT; COCHLEAR IMPLANT

Model Number	CI-1600-05
Health Effect - Clinical Codes	Hematoma (1884); Hemorrhage/Blood Loss/Bleeding (1888); Unspecified Infection (1930)
Date of Event	05/23/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
The recipient reportedly experienced bleeding from external canal after implant surgery on (b)(6) 2021.The recipient was hospitalized.The recipient presented with hemorrhaging in the external auditory canal on (b)(6) 2021.The recipient was given antibiotics which helped reduce the bleeding.There is no evidence that the infection is device related.The recipient was discharged on (b)(6) 2021.The recipient's activation went well.
Additional Manufacturer Narrative
Additional information: sections a.1 & a.2.Advanced bionics considers the investigation into this reportable event as closed.The recipient reportedly experienced a hematoma and no infection.The recipient's issues resolved.The recipient has recovered.This is the final report.Disclaimer: advanced bionics does not intend that this report be any admission of liability, fault or product defect.

• Brand Name: HIRES ULTRA IMPLANT
• Common Device Name: COCHLEAR IMPLANT
• Manufacturer (Section D): ADVANCED BIONICS, LLC; 28515 westinghouse place; valencia CA 91355
• MDR Report Key: 12081661
• Report Number: 3006556115-2021-00853
• Device Sequence Number: 14542670
• Product Code: MCM
• UDI-Device Identifier: 07630016877988
• UDI-Public: (01)07630016877988(11)200811(17)230731
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P960058
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/31/2021

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 Expiration Date: 07/31/2023
• Device Model Number: CI-1600-05
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/28/2021
• Supplement Report FDA Received Date: 07/30/2021
• 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: Hospitalization; Required Intervention
• Patient Age: 29 YR