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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 Bacterial Infection (1735); Inflammation (1932)
Event Type  Injury  
Manufacturer Narrative
Additional information regarding the patient and device were requested; however, not yet made available as of the date of this report.(b)(4).
 
Event Description
Per the clinic, the patient developed recurrent infections, inflammation and skin irritations at the implant site.Subsequently, the patient was treated with antibiotics (type, date and duration not reported).The implanted device remains insitu.
 
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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
macquarie university, nsw 2109,
AS   2109,
94286555
MDR Report Key6348069
MDR Text Key67923886
Report Number6000034-2017-00294
Device Sequence Number1
Product Code LXB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K100360
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 01/26/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/21/2017
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
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/26/2017
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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