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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 Appropriate Term/Code Not Available (3191)
Patient Problem Cellulitis (1768)
Event Type  Injury  
Manufacturer Narrative

This report is submitted on august 14, 2019.

 
Event Description

Per the clinic, the patient experienced cellulitis at abutment site; subsequently the area was excised, and patient was treated with topical and oral antibiotics. The implanted device remains.

 
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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 (Section G)
COCHLEAR BONE ANCHORED SOLUTIONS AB
konstruktionsvägen 14
po box 82
mölnlycke, 43533
SW 43533
Manufacturer Contact
kristel kohne
1 university avenue
macqaurie university, nsw 2109
AS   2109
MDR Report Key8891137
MDR Text Key154369335
Report Number6000034-2019-01471
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 USER FACILITY
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/28/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/13/2019
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? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/28/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient TREATMENT DATA
Date Received: 08/13/2019 Patient Sequence Number: 1
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