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

Model Number 95773

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Swelling (2091)

Event Type  Injury  

Manufacturer Narrative

This report is submitted on may 04, 2018.(b)(4).

Event Description

Per the clinic, the patient experienced swelling and redness at the magnet site.Subsequently the patient was treated with a topical antibiotic for a number of weeks.Following treatment the symptoms reportedly resolved.

• 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; mölnlycke 43533 ; SW 43533
• Manufacturer Contact: sujeewa wijesinghe ; 1 university avenue; macquarie university, nsw 2109 ; AS 2109
• MDR Report Key: 7485904
• MDR Text Key: 107309994
• Report Number: 6000034-2018-00983
• Device Sequence Number: 1
• Product Code: LXB
• UDI-Device Identifier: 09321502028691
• UDI-Public: (01)09321502028691(10)124915(17)201115
• 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: Audiologist
• Type of Report: Initial
• Report Date: 04/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/15/2020
• Device Model Number: 95773
• Device Catalogue Number: 95773
• Device Lot Number: 124915
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/23/2018
• 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