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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB BA400 ABUTMENT 12MM; COCHLEAR BAHA CONNECT SYSTEM
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COCHLEAR BONE ANCHORED SOLUTIONS AB BA400 ABUTMENT 12MM; COCHLEAR BAHA CONNECT SYSTEM Back to Search Results
Model Number 93336
Device Problems Insufficient Information (3190); Appropriate Term/Code Not Available (3191); Patient Device Interaction Problem (4001)
Patient Problems Unspecified Infection (1930); Insufficient Information (4580)
Event Date 08/30/2021
Event Type  Injury  
Event Description
Per the clinic, the device was explanted on (b)(6) 2021.Additional information has been requested but has not been made available as of the date of this report.
 
Event Description
Per the clinic, there was no explantation of device.The abutment was removed on (b)(6) 2021 due to infection at the implant site.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 was treated with oral and topical antibiotics (specific date and duration not reported) and topical steroid (specific date and duration not reported).
 
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Brand Name
BA400 ABUTMENT 12MM
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 Key12551033
MDR Text Key273983036
Report Number6000034-2021-02906
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,Followup
Report Date 12/14/2021,11/22/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/29/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model Number93336
Device Catalogue Number93336
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA12/14/2021
Distributor Facility Aware Date11/22/2021
Event Location Hospital
Date Report to Manufacturer11/22/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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