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

Model Number ASKU

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Host-Tissue Reaction (1297)

Event Date 06/27/2018

Event Type  Injury  

Manufacturer Narrative

Patient details unavailable at the time of this report, this report is submitted on july 20, 2018.(b)(4).

Event Description

It was reported that the patient experienced skin overgrowth at the abutment site and subsequently, underwent a skin revision under a general anaesthetic on (b)(6) 2018.

• Brand Name: ASKU
• 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 Contact: sujeewa wijesinghe ; 1 university avenue; macquarie university, nsw 2109 ; AS 2109
• MDR Report Key: 7705480
• MDR Text Key: 114537957
• Report Number: 6000034-2018-01501
• Device Sequence Number: 1
• Product Code: LXB
• Combination Product (y/n): N
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial
• Report Date: 07/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: ASKU
• Device Catalogue Number: ASKU
• Date Manufacturer Received: 07/05/2018
• 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
• Patient Age: 39 YR