MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB BIM400 IMPLANT MAGNET; COCHLEAR BAHA ATTRACT SYSTEM

Model Number 93550

Device Problems Expulsion (2933); Appropriate Term/Code Not Available (3191)

Patient Problem Swelling/ Edema (4577)

Event Date 04/23/2021

Event Type  Injury  

Manufacturer Narrative

This report is submitted on may 19, 2021.

Event Description

Per the clinic, the patient was administered injectable steroids on (b)(6) 2021 due to swelling around the magnet.

Manufacturer Narrative

Per the clinic, the patient was treated with oral antibiotics (specific date and duration not reported).This report is submitted on july 9, 2021.

Manufacturer Narrative

It was reported the patient experienced an extrusion of the implant magnet through the skin.The patient was treated with topical antibiotics.This report is submitted on november 12, 2021.

• Brand Name: BIM400 IMPLANT MAGNET
• Type of Device: COCHLEAR BAHA ATTRACT SYSTEM
• Manufacturer (Section D): COCHLEAR BONE ANCHORED SOLUTIONS AB; konstruktionsvägen 14; po box 82; mölnlycke, 43533 ; SW 43533
• Manufacturer (Section G): COCHLEAR BONE ANCHORED SOLUTIONS AB; konstruktionsvägen 14; po box 82; mölnlycke, 43533 ; SW 43533
• Manufacturer Contact: weiting zhen ; 1 university avenue; no.8 jalan kerinchi,; macquarie university, nsw 2109 ; AS 2109
• MDR Report Key: 11847167
• MDR Text Key: 251366898
• Report Number: 6000034-2021-01390
• Device Sequence Number: 1
• Product Code: LXB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131240
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/19/2021

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
• Device Model Number: 93550
• Device Catalogue Number: 93550
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/23/2021
• Initial Date FDA Received: 05/19/2021
• Supplement Dates Manufacturer Received: 06/19/2021; 10/19/2021
• Supplement Dates FDA Received: 07/08/2021; 11/11/2021
• 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: 41 YR
• Patient Sex: Female