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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB BAHA FLANGE AND ABUTMENT; LXB: PRODUCT CODE
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COCHLEAR BONE ANCHORED SOLUTIONS AB BAHA FLANGE AND ABUTMENT; LXB: PRODUCT CODE Back to Search Results
Catalog Number 92127
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problems Irritation (1941); Patient Problem/Medical Problem (2688)
Event Date 11/03/2015
Event Type  Injury  
Manufacturer Narrative
The implanted device remains.
 
Event Description
Per the clinic, the patient experienced skin overgrowth on the abutment.On (b)(6) 2015 the patient underwent a revision surgery to have excess skin excised.At the patient's follow up appointment on (b)(6) 2016 redness, irritation and pus were noted; the patient was prescribed antibiotic ointment.The implanted device remains.
 
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Brand Name
BAHA FLANGE AND 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 Key5579540
MDR Text Key42744223
Report Number6000034-2016-00752
Device Sequence Number1
Product Code LXB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K984162
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 03/25/2016
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 Number92127
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/25/2016
Initial Date FDA Received04/14/2016
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;
Patient Age13 YR
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