MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB; COCHLEAR BAHA CONNECT SYSTEM

Device Problems Appropriate Term/Code Not Available (3191); Patient Device Interaction Problem (4001)

Patient Problems Unspecified Infection (1930); Post Operative Wound Infection (2446)

Event Date 08/05/2021

Event Type  Injury  

Event Description

Per the clinic, the recipient developed an infection and the device was explanted on (b)(6) 2021.Additional information has been requested but has not been made available as of the date of this report, september 9, 2021.

Event Description

Correction: only abutment was removed, not the entire device as previously reported.Per the clinic, the patient experienced an infection at the incision site post abutment removal and underwent a surgical procedure to clean the wound (date not reported).This report is submitted on october 05, 2021.

Event Description

Per the clinic, the patient was placed under general anesthesia on (b)(6) 2021 for the abutment removal (as per previously reported).The patient was treated with antibiotics (specific type, date and duration not reported) post surgery.

• Brand Name: NI
• Type of Device: COCHLEAR BAHA CONNECT SYSTEM
• Manufacturer (Section D): COCHLEAR BONE ANCHORED SOLUTIONS AB; konstruktionsvägen 14; mölnlycke, 435 3 3; SW 435 33
• MDR Report Key: 12443996
• MDR Text Key: 270476395
• Report Number: 6000034-2021-02749
• Device Sequence Number: 1
• Product Code: LXB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 11/15/2021,10/25/2021

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/15/2021
• Distributor Facility Aware Date: 10/25/2021
• Event Location: Hospital
• Date Report to Manufacturer: 11/15/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/08/2021
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 10/05/2021; 11/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 89 YR
• Patient Sex: Male