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U.S. Department of Health and Human Services

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

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COCHLEAR BONE ANCHORED SOLUTIONS AB ATTRACT SYSTEM LXB, PRODUCT CODE: Back to Search Results
Catalog Number 93550
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem Seroma (2069)
Event Type  Injury  
Manufacturer Narrative

This report is filed, april 7, 2016. The implanted device remains.

 
Event Description

Per the clinic, the patient developed a seroma at the implant site post implantation. Fluid was drained from the site (date not reported) and the patient was prescribed oral antibiotics (date and duration not reported). The issues have resolved. The implanted device remains.

 
Manufacturer Narrative

Correction: the correct patient identifier is (b)(6); not (b)(6) as previously reported. This report is filed may 2, 2016. The implanted device remains.

 
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Brand NameATTRACT SYSTEM
Type of DeviceLXB, PRODUCT CODE:
Manufacturer (Section D)
COCHLEAR BONE ANCHORED SOLUTIONS AB
konstruktionsvägen 14
po box 82
mölnlycke SE 43 5-22
SW SE 435-22
Manufacturer Contact
nicole hille
13059 east peakview avenue
centennial, CO 80111
3037909010
MDR Report Key5554876
MDR Text Key42079117
Report Number6000034-2016-00714
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 04/08/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/07/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator NO INFORMATION
Device Catalogue Number93550
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 Received03/17/2016
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: 04/07/2016 Patient Sequence Number: 1
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