MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB ABUTMENT 9MM; COCHLEAR BAHA CONNECT SYSTEM

Model Number 91075

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Bacterial Infection (1735); Tissue Breakdown (2681)

Event Type  Injury  

Manufacturer Narrative

This report is submitted on december 19, 2018.Registration number (b)(4).

Event Description

Per the clinic, the patient experienced a skin overgrowth at the abutment site.It was also reported that the patient experienced persistent infections and granulation tissue resulting in the administration of oral and topical antibiotics.

Manufacturer Narrative

This report is submitted on january 5, 2019.Registration number (b)(4).

Event Description

Per the clinic, the patient experienced a skin overgrowth at the abutment site.It was also reported that the patient experienced persistent infections and granulation tissue resulting in the administration of oral and topical antibiotics (date not reported).

• Brand Name: ABUTMENT 9MM
• 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 BONE ANCHORED SOLUTIONS AB; konstruktionsvägen 14; po box 82; mölnlycke 43533 ; SW 43533
• Manufacturer Contact: tamara martin ; 1 university avenue; macquarie university, nsw 2109 ; AS 2109
• MDR Report Key: 8177400
• MDR Text Key: 130767981
• Report Number: 6000034-2018-02440
• Device Sequence Number: 1
• Product Code: LXB
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K955713
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 12/07/2018

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: 91075
• Device Catalogue Number: 91075
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/07/2018
• Initial Date FDA Received: 12/18/2018
• Supplement Dates Manufacturer Received: 12/07/2018
• Supplement Dates FDA Received: 01/04/2019
• Was Device Evaluated by Manufacturer?: No
• 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