MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB CP900 SERIES MAGNET (2 M, CARBON); NUCLEUS 24 COCHLEAR IMPLANT SYSTEM

Model Number CP900 ACCESSORY

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Pressure Sores (2326)

Event Type  Injury  

Manufacturer Narrative

This report is submitted (b)(6) 2017, by (b)(4).

Event Description

Per the clinic, the patient developed a pressure sore at the magnet site.Subsequently, an antibiotic ointment was applied to the affected site (date not reported).

• Brand Name: CP900 SERIES MAGNET (2 M, CARBON)
• Type of Device: NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
• Manufacturer (Section D): COCHLEAR BONE ANCHORED SOLUTIONS AB; konstruktionsvägen 14; po box 82; mölnlycke, 435 2 2; SW 435 22
• Manufacturer Contact: bianca hanlon ; 1 university avenue; macquarie university, nsw 2109, ; AS 2109, ; 94286555
• MDR Report Key: 6390291
• MDR Text Key: 69437418
• Report Number: 6000034-2017-00526
• Device Sequence Number: 1
• Product Code: MCM
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P970051
• 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: 02/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: CP900 ACCESSORY
• Device Catalogue Number: Z285908
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/23/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention