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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 Problems Hematoma (1884); Unspecified Infection (1930)
Event Type  Injury  
Manufacturer Narrative

This report is filed, may 23, 2016. The implanted device remains.

 
Event Description

Per the clinic, the patient developed a wound infection and a hematoma at the incision site post abutment to magnet conversion; the patient was prescribed oral antibiotics on (b)(6) 2016 (duration not reported). On (b)(6) 2016 the patient was prescribed another course of oral antibiotics (duration not reported) as the infection had reoccurred. 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 Key5673837
MDR Text Key45721141
Report Number6000034-2016-01045
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
Report Date 05/07/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/23/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator NO INFORMATION
Device Catalogue Number93550
Device LOT Number103650
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 Received05/07/2016
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: 05/23/2016 Patient Sequence Number: 1
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