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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB BAHA FLANGE & ABUTMENT; LXB: PRODUCT CODE

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COCHLEAR BONE ANCHORED SOLUTIONS AB BAHA FLANGE & ABUTMENT; LXB: PRODUCT CODE Back to Search Results
Catalog Number 92128
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem Discharge (2225)
Event Type  Injury  
Manufacturer Narrative
This report is filed, (b)(6) 2016.The implanted device remains.
 
Event Description
Per the clinic, the patient experienced discharge from the implant site and was treated with silver nitrate (date not reported).The implanted device remains.
 
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Brand Name
BAHA FLANGE & ABUTMENT
Type of Device
LXB: 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 Key5503029
MDR Text Key40386290
Report Number6000034-2016-00550
Device Sequence Number1
Product Code LXB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K955713
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 02/22/2016
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 No Information
Device Catalogue Number92128
Device Lot Number150070
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 02/22/2016
Initial Date FDA Received03/15/2016
Was Device Evaluated by Manufacturer? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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