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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB ASKU; COCHLEAR BAHA ATTRACT SYSTEM
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COCHLEAR BONE ANCHORED SOLUTIONS AB ASKU; COCHLEAR BAHA ATTRACT SYSTEM Back to Search Results
Model Number ASKU
Device Problem Insufficient Information (3190)
Patient Problem No Information (3190)
Event Date 05/11/2020
Event Type  Injury  
Manufacturer Narrative
This report is submitted on 4 june, 2020.
 
Event Description
Per the clinic, the patient underwent revision surgery on (b)(6) 2020, in order to convert the patient to a percutaneous baha implant system.During the procedure, the internal magnet was removed, and an abutment was placed on the internal fixture.Additional information has been requested but has not been made available as of the date of this report, (b)(6) 2020.
 
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Brand Name
ASKU
Type of Device
COCHLEAR BAHA ATTRACT SYSTEM
Manufacturer (Section D)
COCHLEAR BONE ANCHORED SOLUTIONS AB
konstruktionsvägen 14
po box 82
mölnlycke, 435 2 2
SW  435 22
Manufacturer Contact
weiting zhen
1 university avenue
macquarie university, nsw 2109
AS   2109
MDR Report Key10117300
MDR Text Key193914382
Report Number6000034-2020-01394
Device Sequence Number1
Product Code LXB
Combination Product (y/n)N
Reporter Country CodeSZ
PMA/PMN Number
ASKU
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation Other
Type of Report Initial
Report Date 05/13/2020
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 Model NumberASKU
Device Catalogue NumberASKU
Device Lot NumberASKU
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 05/13/2020
Initial Date FDA Received06/03/2020
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 Sequence Number1
Patient Outcome(s) Required Intervention;
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