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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB BIA400 IMPLANT 4MM W ABUTMENT 10MM; COCHLEAR BAHA CONNECT SYSTEM
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COCHLEAR BONE ANCHORED SOLUTIONS AB BIA400 IMPLANT 4MM W ABUTMENT 10MM; COCHLEAR BAHA CONNECT SYSTEM Back to Search Results
Model Number 93331
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes Swelling (2091); Skin Inflammation (2443)
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
This report is submitted on january 15, 2020.
 
Event or Problem Description
Per the clinic, the patient experienced an infection at the abutment site that was treated with oral antibiotics.The implant remains in-situ.
 
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Brand Name
BIA400 IMPLANT 4MM W ABUTMENT 10MM
Common Device Name
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 Key9589615
Report Number6000034-2020-00010
Device Sequence Number16236684
Product Code MAH
UDI-Device Identifier09321502022385
UDI-Public(01)09321502022385(10)COH1280934
Combination Product (Y/N)N
Initial Reporter StateOH
Initial Reporter CountryUS
PMA/510(K) Number
K121317
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Reporter Type Manufacturer
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 12/30/2019
Report Date (Section F) 01/15/2020
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
Operator of Device Lay User/Patient
Device Model Number93331
Device Catalogue Number93331
Device Lot NumberCOH1280934
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Date Report to Manufacturer12/30/2019
Initial Date Received by Manufacturer 12/30/2019
Initial Report FDA Received Date01/14/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
Date Report Sent to FDA01/15/2020
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