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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB UNKNOWN; COCHLEAR BAHA CONNECT SYSTEM
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COCHLEAR BONE ANCHORED SOLUTIONS AB UNKNOWN; COCHLEAR BAHA CONNECT SYSTEM Back to Search Results
Model Number UNKNOWN
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem No Code Available (3191)
Event Date 11/02/2016
Event Type  Injury  
Manufacturer Narrative
Device and initial implantation details unavailable at the time of this report.(b)(4).
 
Event Description
Per the clinic, the patient experienced a lack of clinical benefit leading to non use; subsequently the patient was placed under general anaesthesia on (b)(6) 2016 to remove abutment.
 
Manufacturer Narrative
Correction: the correct outcomes attributed to adverse event is required intervention to prevent permanent impairment/damage (devices).(b)(4).
 
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Brand Name
UNKNOWN
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
macqaurie university, nsw 2109
AS   2109
94286555
MDR Report Key6144024
MDR Text Key61397424
Report Number6000034-2016-02303
Device Sequence Number1
Product Code LXB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
UNKNOWN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Audiologist
Type of Report Initial,Followup
Report Date 11/08/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/04/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model NumberUNKNOWN
Device Catalogue NumberUNKNOWN
Device Lot NumberUNKNOWN
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/08/2016
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;
Patient Age17 YR
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