MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB ATTRACT SYSTEM; LXB: PRODUCT CODE

Catalog Number 95774

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Swelling (2091)

Event Type  Injury  

Manufacturer Narrative

The implanted device remains.

Event Description

Per the clinic, the patient redness and swelling at the magnet site and was prescribed antibiotics (date and duration not reported).The implanted device remains.

• Brand Name: ATTRACT SYSTEM
• Type of Device: LXB: PRODUCT CODE
• Manufacturer (Section D): COCHLEAR BONE ANCHORED SOLUTIONS AB; konstruktionsvagen 14; po box 82; moinlycke SE-43 5 22; SW SE-435 22
• Manufacturer Contact: nicole hille ; 13059 east peakview ave; centennial, CO 80111 ; 3037909010
• MDR Report Key: 5360949
• MDR Text Key: 35692292
• Report Number: 6000034-2016-00102
• 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: company representative
• Reporter Occupation: Audiologist
• Type of Report: Initial
• Report Date: 12/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: 95774
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/21/2015
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention