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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB BIA400 IMPLANT 4MM W ABUTMENT 8MM COCHLEAR BAHA CONNECT SYSTEM

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COCHLEAR BONE ANCHORED SOLUTIONS AB BIA400 IMPLANT 4MM W ABUTMENT 8MM COCHLEAR BAHA CONNECT SYSTEM Back to Search Results
Model Number 93330
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problems Bacterial Infection (1735); Purulent Discharge (1812); Pain (1994)
Event Date 12/17/2018
Event Type  Injury  
Manufacturer Narrative

This report is submitted on october 02, 2018, (b)(4).

 
Event Description

Per the audiologist, it was reported that the patient experienced discharging pus at the wound site on (b)(6) 2018. On (b)(6) 2018 the patient underwent skin revision due to skin overgrowth at the abutment site. In (b)(6) 2018 the patient experienced pain, itchiness and skin overgrowth. It was reported that the patient was administered a topical antibiotic on (b)(6) 2018 for infection. On (b)(6)2018 the abutment was removed. There are plans to place a magnet on the internal fixture but has yet to occur as of the date of this report.

 
Manufacturer Narrative

Per the clinic, it was reported that the patient underwent revision to have a magnet placed on the internal fixture on (b)(6) 2018, converting the patient to a subcutaneous baha implant system. This report is submitted on january 14, 2019.

 
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Brand NameBIA400 IMPLANT 4MM W ABUTMENT 8MM
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
sujeewa wijesinghe
1 university avenue
macqaurie university, nsw 2109
AS   2109
MDR Report Key7925019
MDR Text Key122296361
Report Number6000034-2018-01979
Device Sequence Number1
Product Code LXB
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK121317
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 Received10/02/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL Number93330
Device Catalogue Number93330
Device LOT NumberCOH1135364
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: 10/02/2018 Patient Sequence Number: 1
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