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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB; ENTIFIC MEDICAL SYSTEM AB
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COCHLEAR BONE ANCHORED SOLUTIONS AB; ENTIFIC MEDICAL SYSTEM AB Back to Search Results
Lot Number 0413 06 A 13750
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem Bacterial Infection (1735)
Event Type  Injury  
Manufacturer Narrative
(b)(4).
 
Event Description
Per the clinic, it was reported that the patient experienced infections at the implant site.Subsequently, on (b)(6) 2017, the patient was placed under deep sedation in order to remove the abutment and evaluate the scalp around the fixture.The implanted device remains insitu.
 
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Brand Name
NI
Type of Device
ENTIFIC MEDICAL SYSTEM AB
Manufacturer (Section D)
COCHLEAR BONE ANCHORED SOLUTIONS AB
konstruktionsvägen 14
po box 82
mölnlycke, 435 2 2
SW  435 22
Manufacturer (Section G)
COCHLEAR BONE ANCHORED SOLUTIONS AB
konstruktionsvägen 14
po box 82
mölnlycke 43533
SW   43533
Manufacturer Contact
bianca pries
1 university avenue
macquarie university, nsw 2109
AS   2109
MDR Report Key7046968
MDR Text Key92583567
Report Number6000034-2017-02072
Device Sequence Number1
Product Code LXB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
NI
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 11/01/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/20/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Lot Number0413 06 A 13750
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received11/01/2017
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 Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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