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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, PRODUCT CODE: LXB, PRODUCT CODE:LXB
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COCHLEAR BONE ANCHORED SOLUTIONS AB BAHA ATTRACT SYSTEM; LXB, PRODUCT CODE: LXB, PRODUCT CODE:LXB Back to Search Results
Catalog Number 93550
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem Pain (1994)
Event Date 11/19/2014
Event Type  Injury  
Event Description
Per the clinic, the patient developed pain at the magnet site.The patient was prescribed antibiotics (date and duration not reported).Subsequently, the patient underwent a procedure on (b)(6) 2014 to have the magnet removed and an abutment placed.The implanted device remains.
 
Manufacturer Narrative
Implanted device remains.
 
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Brand Name
BAHA ATTRACT SYSTEM
Type of Device
LXB, PRODUCT CODE: LXB, PRODUCT CODE:LXB
Manufacturer (Section D)
COCHLEAR BONE ANCHORED SOLUTIONS AB
konstruktionsvagen 14
po box 82
molnlycke, se 435 22
SW  435 22
Manufacturer Contact
jennifer campo
13059 east peakview ave.
centennial, CO 80111
3037909010
MDR Report Key4366785
MDR Text Key5111328
Report Number6000031-2014-01796
Device Sequence Number1
Product Code LXB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K131240
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 12/07/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Catalogue Number93550
Device Lot Number89637
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/07/2014
Initial Date FDA Received12/29/2014
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 Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age18 YR
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