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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB BA210 ABUTMENT 5.5MM FOR FLANGE FIXTURE; COCHLEAR BAHA CONNECT SYSTEM
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COCHLEAR BONE ANCHORED SOLUTIONS AB BA210 ABUTMENT 5.5MM FOR FLANGE FIXTURE; COCHLEAR BAHA CONNECT SYSTEM Back to Search Results
Model Number 92132
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem Host-Tissue Reaction (1297)
Event Type  Injury  
Manufacturer Narrative
This report is submitted on (b)(6) 2016.(b)(4).
 
Event Description
Per the clinic, the patient experienced skin overgrowth at the abutment site, however the issue could not be resolved, subsequently the patient was treated with topical and iv steroids (date and duration not reported).The implanted device remains.
 
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Brand Name
BA210 ABUTMENT 5.5MM FOR FLANGE FIXTURE
Type of Device
COCHLEAR BAHA CONNECT SYSTEM
Manufacturer (Section D)
COCHLEAR BONE ANCHORED SOLUTIONS AB
konstruktionsvägen 14
po box 82
mölnlycke, 435 2 2
SW  435 22
Manufacturer Contact
kristel kohne
1 university avenue
macquarie university, nsw 2109,
AS   2109,
94286555
MDR Report Key6157114
MDR Text Key61849818
Report Number6000034-2016-02431
Device Sequence Number1
Product Code LXB
Combination Product (y/n)N
Reporter Country CodeIT
PMA/PMN Number
K955713
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Health Professional
Type of Report Initial
Report Date 11/25/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/08/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model Number92132
Device Catalogue Number92132
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/25/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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