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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB BA300 ABUTMENT 9MM; COCHLEAR BAHA CONNECT SYSTEM
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COCHLEAR BONE ANCHORED SOLUTIONS AB BA300 ABUTMENT 9MM; COCHLEAR BAHA CONNECT SYSTEM Back to Search Results
Model Number 92131
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problems Host-Tissue Reaction (1297); Unspecified Infection (1930)
Event Type  Injury  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the patient experienced infection and skin overgrowth at the abutment site and subsequently underwent skin revision in 2016 (exact date not reported); however, the issue could not be resolved resulting in the decision to remove the abutment.
 
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Brand Name
BA300 ABUTMENT 9MM
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 (Section G)
COCHLEAR BONE ANCHORED SOLUTIONS AB
konstruktionsvägen 14
po box 82
mölnlycke 43533
SW   43533
Manufacturer Contact
sujeewa wijesinghe
1 university avenue
macquarie university, nsw 2109
AS   2109
MDR Report Key7532386
MDR Text Key108850727
Report Number6000034-2018-01067
Device Sequence Number1
Product Code LXB
Combination Product (y/n)N
Reporter Country CodeCO
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 05/08/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/22/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model Number92131
Device Catalogue Number92131
Device Lot Number168976
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received05/08/2018
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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