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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 Problem Bacterial Infection (1735)
Event Type  Injury  
Manufacturer Narrative

(b)(4).

 
Event Description

Per the clinic, the patient experienced infection at the abutment site, subsequently the patient was treated with oral antibiotics (b)(6) 2016 (specific date not reported).

 
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Brand NameBA300 ABUTMENT 9MM
Type of DeviceCOCHLEAR 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
macquarie university, nsw 2109,
AS   2109,
94286555
MDR Report Key6188032
MDR Text Key62784770
Report Number6000034-2016-02450
Device Sequence Number1
Product Code LXB
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK100360
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL
Reporter Occupation AUDIOLOGIST
Type of Report Initial
Report Date 11/29/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/19/2016
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
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/29/2016
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

Patient TREATMENT DATA
Date Received: 12/19/2016 Patient Sequence Number: 1
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