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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
Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
Patient Problem Unspecified Infection (1930)
Event Type  Injury  
Event Description
Per the clinic, the patient experienced an infection around the abutment site (date not reported) and subsequently was treated with antibiotics and steroid (specific type, date and duration not reported).However, the issue could not be resolved.Additional information has been requested but has not been made available as of the date of this report.
 
Event Description
Per the clinic, the patient underwent revision surgery on (b)(6) 2022 in order to have a magnet placed on the internal fixture, converting the patient to a subcutaneous baha implant system.
 
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Brand Name
NI
Type of Device
COCHLEAR BAHA CONNECT SYSTEM
Manufacturer (Section D)
COCHLEAR BONE ANCHORED SOLUTIONS AB
konstruktionsvägen 14
mölnlycke, 435 3 3
SW  435 33
MDR Report Key15230607
MDR Text Key297944099
Report Number6000034-2022-02435
Device Sequence Number1
Product Code MAH
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 12/29/2022,12/06/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/15/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA12/29/2022
Distributor Facility Aware Date12/06/2022
Event Location Hospital
Date Report to Manufacturer12/06/2022
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient SexFemale
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