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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB UNKNOWN; COCHLEAR BAHA CONNECT SYSTEM
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COCHLEAR BONE ANCHORED SOLUTIONS AB UNKNOWN; COCHLEAR BAHA CONNECT SYSTEM Back to Search Results
Model Number ASKU
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem Bacterial Infection (1735)
Event Type  Injury  
Manufacturer Narrative
This report is filed on 07 november 2019.
 
Event Description
Per the clinic, the patient experienced infection at abutment site; subsequently the patient was treated with oral antibiotics (date and duration not reported).
 
Manufacturer Narrative
This report is submitted is submitted on 26 march 2020.
 
Event Description
It was reported that the patient underwent skin revision surgery during the abutment replacement on (b)(6) 2019.
 
Event Description
Per the clinic, it was reported that the patient was placed under general anesthesia in order to remove the abutment.
 
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Brand Name
UNKNOWN
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 Key9288336
MDR Text Key165490194
Report Number6000034-2019-02262
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,Followup
Report Date 03/26/2020,03/02/2020
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
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/26/2020
Distributor Facility Aware Date03/02/2020
Event Location Hospital
Date Report to Manufacturer03/10/2020
Initial Date Manufacturer Received Not provided
Initial Date FDA Received11/06/2019
Supplement Dates Manufacturer ReceivedNot provided
Not provided
Supplement Dates FDA Received03/09/2020
03/25/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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