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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB BIA300 IMPLANT 4MM W ABUTMENT 9MM COCHLEAR BAHA CONNECT SYSTEM

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COCHLEAR BONE ANCHORED SOLUTIONS AB BIA300 IMPLANT 4MM W ABUTMENT 9MM COCHLEAR BAHA CONNECT SYSTEM Back to Search Results
Model Number 92346
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problems Pain (1994); Staphylococcus Aureus (2058); Swelling (2091); Tissue Breakdown (2681)
Event Type  Injury  
Manufacturer Narrative

(b)(4). Product details have been requested but were not made available as of the date of this report. (b)(4).

 
Event Description

Per the audiologist, the patient developed an infection (staph aureus) and experienced pain and swelling at the abutment site. The patient was administered a steroid and topical and oral antibiotics (date not reported); however, the issue did not resolve. Subsequently, the patient experienced skin granulation and underwent revision surgery to cauterize the area with silver nitrate. The abutment was removed on (b)(6) 2018. The patient is being clinically managed by the health care provider.

 
Manufacturer Narrative

It has since been reported that the patient underwent skin revision under general anaesthetic on (b)(6) 2018. Device details have since been provided and sections have been updated. This report is submitted january 9, 2019.

 
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Brand NameBIA300 IMPLANT 4MM W 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 (Section G)
COCHLEAR BONE ANCHORED SOLUTIONS AB
konstruktionsvägen 14
po box 82
mölnlycke, 43533
SW 43533
Manufacturer Contact
tamara martin
1 university avenue
macqaurie university, nsw 2109
AS   2109
MDR Report Key8087943
MDR Text Key127849557
Report Number6000034-2018-02265
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
Type of Report Initial,Followup
Report Date 01/02/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/19/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL Number92346
Device Catalogue Number92346
Device LOT Number89176
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/02/2019
Was Device Evaluated By Manufacturer? No
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 11/19/2018 Patient Sequence Number: 1
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