MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB BA400 ABUTMENT 8MM; COCHLEAR BAHA CONNECT SYSTEM

Model Number	93334
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Impaired Healing (2378)
Date of Event	12/07/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This report is submitted on january 02, 2024.
Event or Problem Description
Per the clinic, the patient experienced a skin overgrowth over the abutment site and subsequently, underwent a skin revision surgery on (b)(3) 2023 in order to debride the overgrown skin.

• Brand Name: BA400 ABUTMENT 8MM
• 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: thevamalar jayamagentharan ; unit ug-1, vertical podium; no. 8 jalan kerinchi,; kuala lumpur, wilayah persekutuan 59200 ; MY 59200
• MDR Report Key: 18423521
• Report Number: 6000034-2024-00025
• Device Sequence Number: 7743121
• Product Code: MAH
• UDI-Device Identifier: 09321502022743
• UDI-Public: (01)09321502022743(10)177236(17)230615
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K121317
• 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
• Type of Report: Initial
• Report Date (Section B): 12/07/2023

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: 06/15/2023
• Device Model Number: 93334
• Device Catalogue Number: 93334
• Device Lot Number: 177236
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/07/2023
• Initial Report FDA Received Date: 01/02/2024
• 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 Age: 21 YR
• Patient Sex: Female