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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 Insufficient Information (3190)
Patient Problem Unspecified Infection (1930)
Event Date 11/13/2019
Event Type  Injury  
Manufacturer Narrative
Additional information has been requested regarding the infection details, treatment and 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 (b)(6) 2019.
 
Event Description
Per the clinic, it was reported that the device was explanted on (b)(6) 2019, due to a severe infection.
 
Manufacturer Narrative
Correction: the device was not explanted as previously reported.The abutment was removed under general anaesthetic and the device remains in-situ.This report is submitted on 1 may 2010.
 
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Brand Name
ASKU
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 Key9528699
MDR Text Key172995400
Report Number6000034-2019-02907
Device Sequence Number1
Product Code LXB
Combination Product (y/n)N
PMA/PMN Number
NI
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 04/12/2020
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 12/05/2019
Initial Date FDA Received12/29/2019
Supplement Dates Manufacturer Received04/12/2020
Supplement Dates FDA Received04/30/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age6 YR
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