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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 6MM COCHLEAR BAHA CONNECT SYSTEM

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COCHLEAR BONE ANCHORED SOLUTIONS AB BIA300 IMPLANT 4MM W ABUTMENT 6MM COCHLEAR BAHA CONNECT SYSTEM Back to Search Results
Model Number 92127
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problems Host-Tissue Reaction (1297); Scarring (2061)
Event Date 09/14/2017
Event Type  Injury  
Manufacturer Narrative

This report is submitted on october 03, 2017, (b)(4).

 
Event Description

Per the clinic, the patient experienced skin overgrowth and a hypertrophic scarring at abutment site. Subsequently, the patient underwent revision surgery under general anesthesia to remove the skin overgrowth and hypertrophic scarring. During the procedure, a longer abutment was placed. The patient will continue to be clinically monitored by their healthcare provider.

 
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Brand NameBIA300 IMPLANT 4MM W ABUTMENT 6MM
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
sujeewa wijesinghe
1 university avenue
macquarie university, nsw 2109
AS   2109
MDR Report Key6909921
MDR Text Key87979966
Report Number6000034-2017-01772
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 HEALTH PROFESSIONAL
Type of Report Initial
Report Date 09/14/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/03/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL Number92127
Device Catalogue Number92127
Device LOT Number93636
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received09/14/2017
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 TREATMENT DATA
Date Received: 10/03/2017 Patient Sequence Number: 1
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