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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB ASKU COCHLEAR BAHA CONNECT SYSTEM

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COCHLEAR BONE ANCHORED SOLUTIONS AB ASKU COCHLEAR BAHA CONNECT SYSTEM Back to Search Results
Model Number ASKU
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Unspecified Infection (1930)
Event Type  Injury  
Manufacturer Narrative

This report is submitted on december 18, 2020.

 
Event Description

Per the clinic, the abutment was removed due to an infection. Treatment for the infection is unknown.

 
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Brand NameASKU
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 Key11033365
MDR Text Key222270775
Report Number6000034-2020-03477
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 01/28/2021,01/05/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/17/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL NumberASKU
Was Device Available For Evaluation? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/28/2021
Distributor Facility Aware Date01/05/2021
Event Location No Information
Date Report TO Manufacturer10/28/2020
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: 12/17/2020 Patient Sequence Number: 1
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