MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB SP MAGNET 4; COCHLEAR BAHA ATTRACT SYSTEM

Model Number	95774
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Bacterial Infection (1735)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This report is submitted on august 10, 2018.Registration number (b)(4).Exemption number (b)(4).
Event or Problem Description
Per the clinic, the patient developed an infection; subsequently antibiotics were administered (date not reported) and the magnet was replaced.

• Brand Name: SP MAGNET 4
• Common Device Name: COCHLEAR BAHA ATTRACT SYSTEM
• Manufacturer (Section D): COCHLEAR BONE ANCHORED SOLUTIONS AB; konstruktionsvägen 14; po box 82; mölnlycke, 435 2 2; SW 435 22
• MDR Report Key: 7770809
• Report Number: 6000034-2018-01688
• Device Sequence Number: 11278021
• Product Code: LXB
• UDI-Device Identifier: 09321502028684
• UDI-Public: (01)09321502028684(10)124556(17)190302
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K131240
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/25/2018

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 03/02/2019
• Device Model Number: 95774
• Device Catalogue Number: 95774
• Device Lot Number: 124556
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/25/2018
• Initial Report FDA Received Date: 08/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention