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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 Patient Device Interaction Problem (4001)
Patient Problems Scar Tissue (2060); Discomfort (2330)
Event Type  Injury  
Event Description
Per the clinic, the patient experienced discomfort and skin redundancy at the abutment site.The patient underwent a procedure (specific date not reported) for a resection of the redundant scar tissue, and a soft tissue reduction.The implanted device remains.
 
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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 Key11510062
MDR Text Key240562744
Report Number6000034-2021-00931
Device Sequence Number1
Product Code LXB
UDI-Device Identifier09321502019767
UDI-Public(01)09321502019767(10)95542(17)161130
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation Other
Type of Report Initial
Report Date 03/18/2021,02/16/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Expiration Date11/30/2016
Device Model Number92346
Device Catalogue Number92346
Device Lot Number95542
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/18/2021
Distributor Facility Aware Date02/16/2021
Initial Date Manufacturer Received Not provided
Initial Date FDA Received03/17/2021
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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