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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 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.

 
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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 Key5663893
MDR Text Key45419129
Report Number6000034-2016-00982
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
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 Received05/18/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator NO INFORMATION
Device MODEL NumberN/A
Device Catalogue Number93550
Device LOT Number107243
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 Received04/27/2016
Was Device Evaluated By Manufacturer? No
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 05/18/2016 Patient Sequence Number: 1
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