MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB BI300 IMPLANT 4 MM; COCHLEAR BAHA CONNECT SYSTEM

Model Number 92129

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Purulent Discharge (1812); Unspecified Infection (1930); Pain (1994); Swelling/ Edema (4577)

Event Type  Injury  

Manufacturer Narrative

This report is submitted on february 9, 2022.

Event Description

Per the clinic, the patient experienced pain and granulation at abutment site (date not reported) which was treated with a steroid injection on (b)(6) 2021, and oral steroids (duration not reported).However, the issue did not resolve.The patient was then prescribed oral antibiotics for a duration of 10 days on (b)(6) 2021, and topical antibiotics on (b)(6) 2021 (duration not reported).On (b)(6) 2021, the patient experienced infection and discharge which was treated with oral antibiotics (duration not reported), however, the symptoms did not resolve.Subsequently, the patient was prescribed with another round of oral antibiotics on (b)(6) 2021, for a duration of 10 days.On (b)(6) 2021, the patient experienced swelling, redness and crusting overgrowing the abutment site which was resolved on (b)(6) 2021.

Manufacturer Narrative

Per the clinic, the device was explanted on (b)(6) 2022.This report is submitted on may 06, 2022.

• Brand Name: BI300 IMPLANT 4 MM
• 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: thanaletchumi manogaran ; unit ug-1, vertical podium; no. 8 jalan kerinchi,; kuala lumpur, wilayah persekutuan 59200 ; MY 59200
• MDR Report Key: 13494830
• MDR Text Key: 285316729
• Report Number: 6000034-2022-00378
• Device Sequence Number: 1
• Product Code: LXB
• Combination Product (y/n): N
• Reporter Country Code: US
• 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,Followup
• Report Date: 04/17/2022

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
• Device Operator: Lay User/Patient
• Device Model Number: 92129
• Device Catalogue Number: 92129
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/15/2021
• Initial Date FDA Received: 02/09/2022
• Supplement Dates Manufacturer Received: 04/17/2022
• Supplement Dates FDA Received: 05/07/2022
• 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: Male