MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB SP MAGNET 3; COCHLEAR BAHA ATTRACT SYSTEM

Model Number 93563

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problems Erythema (1840); Skin Infection (4544)

Event Date 12/31/2022

Event Type  Injury  

Manufacturer Narrative

This report is submitted on april 28, 2023.

Event Description

Per the clinic, the patient experienced skin erythema and an infection at the magnet site which was successfully treated with a topical antibiotic.The implant and magnet remain in-situ.

• Brand Name: SP MAGNET 3
• Type of Device: COCHLEAR BAHA ATTRACT 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: roberta loveday ; 1 university avenue; macquarie university, 2109 ; AS 2109
• MDR Report Key: 16828563
• MDR Text Key: 314153592
• Report Number: 6000034-2023-01335
• Device Sequence Number: 1
• Product Code: LXB
• UDI-Device Identifier: 09321502028691
• UDI-Public: (01)09321502028691(10)COH1414227(11)10062020(17)04092030
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K131240
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/09/2023

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: 93563
• Device Catalogue Number: 93563
• Device Lot Number: COH1414227
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/09/2023
• Initial Date FDA Received: 04/27/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/06/2020
• 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: 53 YR
• Patient Sex: Female