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

Model Number	95470
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This report is submitted on september 14, 2017, (b)(4).
Event or Problem Description
Per the patient's audiologist, the patient reportedly experienced bleeding at the site of the processor, and was subsequently treated with a topical antibiotic ointment.It was reported that the patient was wearing their baha processing device on another manufacturer's rigid metal headband, and that the patient's is implanted with another manufacturer's fixture.It is unknown how the processing device was affixed to the headband, and whether or not this may have contributed to the patient's symptoms.The patient will continue to be clinically managed.

• Brand Name: BAHA 5 POWER 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: 6863763
• Report Number: 6000034-2017-01746
• Device Sequence Number: 19184404
• Product Code: LXB
• UDI-Device Identifier: 09321502034586
• UDI-Public: (01)09321502034586(11)170202
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K161123
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Audiologist
• Type of Report: Initial
• Report Date (Section B): 09/11/2017

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: 95470
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/11/2017
• Initial Report FDA Received Date: 09/13/2017
• 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