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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB BA300 ABUTMENT 6MM COCHLEAR BAHA CONNECT SYSTEM

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COCHLEAR BONE ANCHORED SOLUTIONS AB BA300 ABUTMENT 6MM COCHLEAR BAHA CONNECT SYSTEM Back to Search Results
Model Number 92130
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problems Host-Tissue Reaction (1297); Unspecified Infection (1930)
Event Type  Injury  
Manufacturer Narrative

This report is submitted on august 3, 2020.

 
Event Description

Per the clinic, the patient experienced an infection and skin overgrowth at the abutment site, which was treated with a topical antibiotic and steroid cream (date and duration not reported). The implanted device remains.

 
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Brand NameBA300 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
weiting zhen
1 university avenue
macquarie university, nsw 2109
AS   2109
MDR Report Key10354661
MDR Text Key201362401
Report Number6000034-2020-01964
Device Sequence Number1
Product Code LXB
Combination Product (Y/N)N
PMA/PMN NumberK100360
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER
Type of Report Initial
Report Date 07/10/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/03/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL Number92130
Device Catalogue Number92130
Device LOT NumberASKU
Was Device Available For Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/10/2020
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: 08/03/2020 Patient Sequence Number: 1
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