MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB FLANGE FIXTURE ST 4MM W. BAHA ABUTMENT; COCHLEAR BAHA CONNECT SYSTEM

Model Number 90434

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Swelling (2091)

Event Type  Injury  

Manufacturer Narrative

This report is submitted on may 16, 2019.(b)(4).

Event Description

Per the surgeon, the patient experienced swelling at the abutment site and subsequently underwent a skin revision and abutment change on (b)(6) 2019, under a local anaesthesia.

• Brand Name: FLANGE FIXTURE ST 4MM W. BAHA ABUTMENT
• 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; 43533 ; SW 43533
• Manufacturer Contact: tamara martin ; 1 university avenue; macquarie university, nsw 2109 ; AS 2109
• MDR Report Key: 8614264
• MDR Text Key: 145210896
• Report Number: 6000034-2019-00732
• Device Sequence Number: 1
• Product Code: LXB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K955713
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 90434
• Device Catalogue Number: 90434
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/23/2019
• 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