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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 12MM COCHLEAR BAHA CONNECT SYSTEM

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COCHLEAR BONE ANCHORED SOLUTIONS AB BIA400 IMPLANT 4MM W ABUTMENT 12MM COCHLEAR BAHA CONNECT SYSTEM Back to Search Results
Model Number 93332
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problems Purulent Discharge (1812); Impaired Healing (2378)
Event Type  Injury  
Manufacturer Narrative

This report is submitted on september 10, 2019.

 
Event Description

Per the clinic, the patient experienced healing issues at the implant site, resulting in purulent discharge from the site. Subsequently, the patient applied a topical antibiotic to the site and the symptoms subsided (date not reported).

 
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Brand NameBIA400 IMPLANT 4MM W ABUTMENT 12MM
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
bianca pries
1 university avenue
macquarie university, nsw 2109
AS   2109
MDR Report Key8978449
MDR Text Key157040016
Report Number6000034-2019-01743
Device Sequence Number1
Product Code LXB
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberNI
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial
Report Date 08/27/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/10/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL Number93332
Device Catalogue Number93332
Device LOT NumberASKU
Was Device Available For Evaluation? No Answer Provided
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/27/2019
Was Device Evaluated By Manufacturer? No Answer Provided
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: 09/10/2019 Patient Sequence Number: 1
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