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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB COCHLEAR BAHA ATTRACT SYSTEM LXB
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COCHLEAR BONE ANCHORED SOLUTIONS AB COCHLEAR BAHA ATTRACT SYSTEM LXB Back to Search Results
Model Number N/A
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem Hematoma (1884)
Event Date 09/16/2016
Event Type  Injury  
Manufacturer Narrative

This report is filed on october 06, 2016. (b)(4). Implanted device remains.

 
Event Description

Per the clinic, the patient experienced post surgery hematoma at implant site; subsequently the patient underwent a procedure on (b)(6) 2016 to drain hematoma.

 
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Brand NameCOCHLEAR BAHA ATTRACT SYSTEM
Type of DeviceLXB
Manufacturer (Section D)
COCHLEAR BONE ANCHORED SOLUTIONS AB
konstruktionsvägen 14
po box 82
mölnlycke, 435 2 2
SW 435 22
Manufacturer (Section G)
COCHLEAR AMERICAS
13059 east parkview avenue
centennial CO 80111
Manufacturer Contact
kristel kohne
1 university avenue
macqaurie university, nsw 2109
AS   2109
2 9428 655
MDR Report Key6002042
MDR Text Key56535433
Report Number6000034-2016-01958
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 HEALTH PROFESSIONAL
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial
Report Date 09/19/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/05/2016
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 NumberCOH896379
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Distributor Facility Aware Date09/19/2016
Event Location No Information
Date Manufacturer Received09/19/2016
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: 10/05/2016 Patient Sequence Number: 1
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