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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 Hematoma (1884)
Event Date 04/22/2016
Event Type  Injury  
Manufacturer Narrative

This report is filed, may 24, 2016. The implanted device remains.

 
Event Description

Per the clinic, the patient developed a hematoma at the incision site post abutment to magnet conversion. On (b)(6) 2016 the patient was prescribed a five day course of oral antibiotics. On (b)(6) 2016 and (b)(6) 2016 the hematoma was drained; the patient was prescribed a second course of oral antibiotics on (b)(6) 2016. On (b)(6) 2016 the incision was packed with gauze. As of (b)(6) 2016 the site has healed. The implanted device remains.

 
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Brand NameATTRACT SYSTEM
Type of DeviceLXB: PRODUCT CODE
Manufacturer (Section D)
COCHLEAR BONE ANCHORED SOLUTIONS AB
konstruktionsvagen 14
po box 82
moinlycke SE-43 5 22
SW SE-435 22
Manufacturer Contact
nicole hille
13059 east peakview ave
centennial, CO 80111
3037909010
MDR Report Key5676126
MDR Text Key45796537
Report Number6000034-2016-01026
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
Report Date 05/09/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/24/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator NO INFORMATION
Device Catalogue Number93550
Device LOT Number108997
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 Received05/09/2016
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: 05/24/2016 Patient Sequence Number: 1
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