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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 Appropriate Term/Code Not Available (3191)
Patient Problems Abscess (1690); Bacterial Infection (1735); Staphylococcus Aureus (2058)
Event Date 07/23/2015
Event Type  Death  
Manufacturer Narrative

Additional information was requested regarding the product details; however, were not made available as of the date of this report. This report is submitted on march 5, 2018, (b)(4).

 
Event Description

Per the clinic, it was reported that the patient experienced recurrent skin infections and overgrowth at the implant site. The first occurrence, on (b)(6) 2015, was treated with oral antibiotics. The second occurrence on (b)(6) 2016, the patient presented with a small abscess. Cultures returned staphylococcus aureus and streptococcal, therefore the patient was treated with oral and topical antibiotics. On (b)(6) 2017, the patient presented to the ed with an infection and drainage at the implant site. Subsequently, the patient was treated with oral and topical antibiotics. On (b)(6) 2017, the patient was seen for follow up and treated with an additional course of oral antibiotics. On (b)(6) 2018, the patient's abutment was removed. Cultures returned multiple organisms, and the patient was treated once more with oral antibiotics. The patient has discontinued use of the device; however, the fixture remains insitu.

 
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Brand NameASKU
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
bianca pries
1 university avenue
macquarie university, nsw 2109
AS   2109
MDR Report Key7312365
MDR Text Key101460996
Report Number6000034-2018-00504
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 HEALTH PROFESSIONAL
Type of Report Initial
Report Date 02/13/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/04/2018
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 Answer Provided
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received02/13/2018
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 Initial

Patient TREATMENT DATA
Date Received: 03/04/2018 Patient Sequence Number: 1
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