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U.S. Department of Health and Human Services

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

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COCHLEAR BONE ANCHORED SOLUTIONS AB BAHA ATTRACT SYSTEM LXB Back to Search Results
Model Number N/A
Device Problem Insufficient Information (3190)
Patient Problems Nausea (1970); Pain (1994)
Event Date 11/24/2015
Event Type  Injury  
Manufacturer Narrative

This report is filed, january 8, 2016. The implanted device remains.

 
Event Description

Per the clinic, the patient was hospitalized on (b)(6) 2015 (duration not reported) for pain in her head and nausea; it is unclear at this time if these symptoms are related to the device. The patient was treated with antibiotics. The implanted device remains.

 
Manufacturer Narrative

Per the clinic, the patient was prescribed a prednisone taper for previously reported issues.

 
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Brand NameBAHA ATTRACT SYSTEM
Type of DeviceLXB
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 Key5354114
MDR Text Key35401292
Report Number6000034-2016-00087
Device Sequence Number1
Product Code LXB
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK131240
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE
Reporter Occupation AUDIOLOGIST
Type of Report Initial,Followup
Report Date 01/06/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/08/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL NumberN/A
Device Catalogue Number92129
Device LOT Number171499
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/18/2015
Was Device Evaluated By Manufacturer? No
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 01/08/2016 Patient Sequence Number: 1
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