MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB BA310 ABUTMENT 6MM; COCHLEAR BAHA CONNECT SYSTEM

Model Number P1340894

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Impaired Healing (2378)

Event Type  Injury  

Event Description

Per the clinic, the patient was administered with oral antibiotics (specific date and duration not reported).Subsequently, the patient was placed under general anesthesia on (b)(6) 2023 in order to remove the abutment due to skin overgrowth.

Manufacturer Narrative

This report is submitted on september 20, 2023.

• Brand Name: BA310 ABUTMENT 6MM
• Type of Device: 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: rosdeelaila zulkifli ; unit ug-1, vertical podium; no. 8 jalan kerinchi,; kuala lumpur, wilayah persekutuan 59200 ; MY 59200
• MDR Report Key: 17779203
• MDR Text Key: 323784834
• Report Number: 6000034-2023-03050
• Device Sequence Number: 1
• Product Code: LXB
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K100360
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/30/2023

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
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/11/2024
• Device Model Number: P1340894
• Device Catalogue Number: P1340894
• Device Lot Number: COH1275764
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/30/2023
• Initial Date FDA Received: 09/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female