MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB BAHA 5 SOUNDPROCESSOR, BLONDE; COCHLEAR BAHA CONNECT SYSTEM

Model Number	95201
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Swelling (2091); Patient Problem/Medical Problem (2688)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
Per the clinic, the patient experienced skin swollen over the abutment.Treatment with steroid injections were successful.
Event or Problem Description
Correction: the recipient experienced swollen and pain are related to the abutment, and not to the sound processor.The abutment product detail not reported to cochlear.
Additional Manufacturer Narrative
Correction: the recipient experienced swollen and pain are related to the abutment, and not to the sound processor.The abutment product detail not reported to cochlear.This report is submitted on october 21, 2019, by cochlear ltd.

• Brand Name: BAHA 5 SOUNDPROCESSOR, BLONDE
• Common Device Name: COCHLEAR BAHA CONNECT SYSTEM
• Manufacturer (Section D): COCHLEAR BONE ANCHORED SOLUTIONS AB; konstruktionsvägen 14; po box 82; mölnlycke, 435 2 2; SW 435 22
• MDR Report Key: 8933483
• Report Number: 6000034-2019-01589
• Device Sequence Number: 13525616
• Product Code: LXB
• UDI-Device Identifier: 09321502028783
• UDI-Public: 09321502028783
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/01/2019
• Report Date (Section F): 08/27/2019

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: 95201
• Device Catalogue Number: 95201
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/15/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/26/2019
• Supplement Report FDA Received Date: 10/21/2019
• 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
• Date Report Sent to FDA: 08/27/2019