MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB BA400 ABUTMENT 12MM; COCHLEAR BAHA CONNECT SYSTEM

Model Number	93336
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Unspecified Infection (1930)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This report is submitted on december 16, 2022.
Event or Problem Description
Per the clinic, the patient experienced an infection at the abutment site and was treated with a combination of steroid and antibiotic ointment (specific date and duration not reported).The patient was also prescribed with oral antibiotics for two weeks (specific date not reported).Additional information has been requested but has not been made available as of the date of this report.

• Brand Name: BA400 ABUTMENT 12MM
• Common Device Name: COCHLEAR BAHA CONNECT SYSTEM
• Manufacturer (Section D): COCHLEAR BONE ANCHORED SOLUTIONS AB; konstruktionsvägen 14; mölnlycke, 435 3 3; SW 435 33
• Manufacturer (Section G): COCHLEAR BONE ANCHORED SOLUTIONS AB; konstruktionsvägen 14; mölnlycke, 435 3 3; SW 435 33
• Manufacturer Contact: yaneesa vetsandonphong ; unit ug-1, vertical podium; no.8 jalan kerinchi,; kuala lumpur, wilayah persekutuan 59200 ; MY 59200
• MDR Report Key: 15994522
• Report Number: 6000034-2022-03830
• Device Sequence Number: 17629779
• Product Code: MAH
• UDI-Device Identifier: 09321502022767
• UDI-Public: (01)09321502022767(10)175115(17)230221
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K121317
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/24/2022

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: 02/21/2023
• Device Model Number: 93336
• Device Catalogue Number: 93336
• Device Lot Number: 175115
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/24/2022
• Initial Report FDA Received Date: 12/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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
• Patient Sex: Male