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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 9MM; COCHLEAR BAHA CONNECT SYSTEM
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COCHLEAR BONE ANCHORED SOLUTIONS AB BIA300 IMPLANT 4MM W ABUTMENT 9MM; COCHLEAR BAHA CONNECT SYSTEM Back to Search Results
Model Number 92346
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Unspecified Infection (1930); Fluid Discharge (2686); Swelling/ Edema (4577)
Event Type  Injury  
Manufacturer Narrative
This report is submitted on february 18, 2021.
 
Event Description
Per the clinic, the patient experienced an infection with swelling and drainage from the abutment site that was treated with a topical antibiotic and steroid.The implant remains in-situ.
 
Event Description
It is now reported that the abutment was changed under a general anaesthetic on march 3, 2021.
 
Manufacturer Narrative
It is now reported that the abutment was changed under a general anaesthetic on march 3, 2021.This report is submitted on april 1, 2021.
 
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Brand Name
BIA300 IMPLANT 4MM W ABUTMENT 9MM
Type of Device
COCHLEAR BAHA CONNECT SYSTEM
Manufacturer (Section D)
COCHLEAR BONE ANCHORED SOLUTIONS AB
konstruktionsvägen 14
po box 82
mölnlycke, 435 2 2
SW  435 22
MDR Report Key11341145
MDR Text Key232319809
Report Number6000034-2021-00445
Device Sequence Number1
Product Code LXB
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Type of Report Initial,Followup
Report Date 04/01/2021,03/05/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/17/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model Number92346
Device Catalogue Number92346
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/01/2021
Distributor Facility Aware Date03/05/2021
Date Report to Manufacturer03/05/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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