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U.S. Department of Health and Human Services

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

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COCHLEAR BONE ANCHORED SOLUTIONS AB COCHLEAR BAHA CONNECT SYSTEM Back to Search Results
Model Number ASKU
Device Problem Patient Device Interaction Problem (4001)
Patient Problem Host-Tissue Reaction (1297)
Event Date 10/25/2019
Event Type  Injury  
Manufacturer Narrative

Additional information has been requested regarding the device details; however, have not been made available as of the date of this report. Should further information be provided, a supplementary report shall be submitted. This report is submitted on december 9, 2019.

 
Event Description

Per the clinic, the patient underwent revision on (b)(6) 2019, in order to excise skin at the implant site. Revision surgery was successful and the implanted device remains insitu.

 
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Brand NameNI
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 Key9435149
MDR Text Key169796502
Report Number6000034-2019-02669
Device Sequence Number1
Product Code LXB
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberNI
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL
Reporter Occupation
Type of Report Initial
Report Date 11/15/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/08/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL NumberASKU
Device Catalogue NumberASKU
Device LOT NumberASKU
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 Received11/15/2019
Was Device Evaluated By Manufacturer? No
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: 12/08/2019 Patient Sequence Number: 1
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