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  

Manufacturer Narrative

This report is submitted on september 9, 2021.

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.

Manufacturer Narrative

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.

Manufacturer Narrative

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.This report is submitted on november 15, 2021.

• 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
• Manufacturer (Section G): COCHLEAR BONE ANCHORED SOLUTIONS AB; konstruktionsvägen 14; mölnlycke, 435 3 3; SW 435 33
• Manufacturer Contact: yaneesa vetsandonphong ; unit ug-1, vertical podium; no.8 jalan kerinchi,; kuala lumpur, wilayah persekutuan 59200 ; MY 59200
• MDR Report Key: 12443997
• MDR Text Key: 270476470
• Report Number: 6000034-2021-02748
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 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
• Initial Date Manufacturer Received: 08/20/2021
• Initial Date FDA Received: 09/08/2021
• Supplement Dates Manufacturer Received: 09/13/2021; 10/25/2021
• Supplement Dates FDA Received: 10/05/2021; 11/15/2021
• 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
• Patient Age: 89 YR
• Patient Sex: Male