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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB FLANGE FIXTURE ST 4MM COCHLEAR BAHA CONNECT SYSTEM

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COCHLEAR BONE ANCHORED SOLUTIONS AB FLANGE FIXTURE ST 4MM COCHLEAR BAHA CONNECT SYSTEM Back to Search Results
Model Number 90432
Device Problem Patient Device Interaction Problem (4001)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 11/23/2020
Event Type  Injury  
Event Description

Per the clinic, the patient experienced skin overgrowth on the abutment. The patient underwent a procedure on (b)(6) 2020, in order to remove overgrown tissue. The implanted device remains.

 
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Brand NameFLANGE FIXTURE ST 4MM
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
MDR Report Key11092509
MDR Text Key224243873
Report Number6000034-2020-03606
Device Sequence Number1
Product Code LXB
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation
Type of Report Initial
Report Date 12/30/2020,12/02/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/29/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL Number90432
Device Catalogue Number90432
Device LOT Number005CMC
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA12/30/2020
Distributor Facility Aware Date12/02/2020
Event Location No Information
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient TREATMENT DATA
Date Received: 12/29/2020 Patient Sequence Number: 1
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