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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 Problems Unspecified Infection (1930); Pain (1994); Swelling (2091)
Event Type  Injury  
Manufacturer Narrative
Device and initial implantation details unavailable at the time of this report.(b)(4).
 
Event Description
It was reported that the patient experienced pain, infection and swelling at abutment site, the abutment was removed.Clinical management is ongoing.The implanted device remains.
 
Manufacturer Narrative
Per the clinic, the patient was treated with oral antibiotics (date and duration not reported).This report is submitted (b)(6) 2017.
 
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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
bianca hanlon
1 university avenue
macqaurie university, nsw 2109
AS   2109
94286555
MDR Report Key6153157
MDR Text Key61696014
Report Number6000034-2016-02338
Device Sequence Number1
Product Code LXB
Combination Product (y/n)N
PMA/PMN Number
UNKNOWN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,health professional
Type of Report Initial,Followup
Report Date 12/08/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/07/2016
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
Was Device Available for Evaluation? No
Date Manufacturer Received12/08/2016
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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