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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB BI300 IMPLANT 3MM COCHLEAR BAHA CONNECT SYSTEM

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COCHLEAR BONE ANCHORED SOLUTIONS AB BI300 IMPLANT 3MM COCHLEAR BAHA CONNECT SYSTEM Back to Search Results
Model Number 92128
Device Problem Patient Device Interaction Problem (4001)
Patient Problem Patient Problem/Medical Problem (2688)
Event Date 09/06/2019
Event Type  Injury  
Manufacturer Narrative

This report is submitted on october 9, 2019.

 
Event Description

Per the clinic, it was reported that the patient experienced skin overgrowth at the implant site. Topical ointment was applied to the site; however, the issue did not resolve. Subsequently, the patient underwent revision surgery on (b)(6) 2019, in order to excise excess skin and place a longer abutment.

 
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Brand NameBI300 IMPLANT 3MM
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 Key9170031
MDR Text Key161662716
Report Number6000034-2019-02077
Device Sequence Number1
Product Code LXB
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberNIK100360
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL
Reporter Occupation PHYSICIAN ASSISTANT
Type of Report Initial
Report Date 09/19/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/08/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date08/31/2019
Device MODEL Number92128
Device Catalogue Number92128
Device LOT Number162074
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/19/2019
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: 10/08/2019 Patient Sequence Number: 1
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