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

Model Number N/A

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Seroma (2069)

Event Date 04/27/2016

Event Type  Injury  

Manufacturer Narrative

This report is filed, may 18, 2016.The implanted device remains.

Event Description

Per the clinic, the patient developed a seroma at the magnet site; on (b)(6) 2016 the site was drained.The implanted device remains.

Manufacturer Narrative

Per the clinic, the patient experienced skin breakdown at the magnet site and was prescribed a two week course of oral antibiotics.The implanted device remains.This report is filed july 21, 2016.

• Brand Name: BAHA ATTRACT SYSTEM
• Type of Device: LXB
• Manufacturer (Section D): COCHLEAR BONE ANCHORED SOLUTIONS AB; konstruktionsvägen 14; po box 82; mölnlycke, se 435-2 2; SW 435-22
• Manufacturer Contact: angel wright ; 13059 east peakview avenue; centennial, CO 80111 ; 3037909010
• MDR Report Key: 5663893
• MDR Text Key: 45419129
• Report Number: 6000034-2016-00982
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 05/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: N/A
• Device Catalogue Number: 93550
• Device Lot Number: 107243
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/27/2016
• 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
• Patient Age: 69 YR