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

Model Number 95202

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Bacterial Infection (1735)

Event Type  Injury  

Manufacturer Narrative

This report is submitted on 17 mar 2021.

Event Description

It was reported that the patient experienced an infection and subsequently was treated with antibiotics (specific date is not reported).

• Brand Name: BAHA 5 SOUNDPROCESSOR, BLACK
• Type of Device: COCHLEAR BAHA CONNECT SYSTEM
• Manufacturer (Section D): COCHLEAR BONE ANCHORED SOLUTIONS AB; konstruktionsvägen 14; po box 82; mölnlycke, 435 2 2; SW 435 22
• Manufacturer (Section G): COCHLEAR LIMITED; 1 university avenue; macquarie university; nsw 2109 ; AS 2109
• Manufacturer Contact: durga velayutham ; unit ug-1, vertical podium; no.8 jalan kerinchi,; kuala lumpur, wilayah persekutuan 59200 ; MY 59200
• MDR Report Key: 11499924
• MDR Text Key: 240292008
• Report Number: 6000034-2021-00873
• Device Sequence Number: 1
• Product Code: LXB
• Combination Product (y/n): N
• PMA/PMN Number: K142907
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial
• Report Date: 02/22/2021

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 Model Number: 95202
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/22/2021
• Initial Date FDA Received: 03/16/2021
• 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