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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB BA400 ABUTMENT 6MM; COCHLEAR BAHA CONNECT SYSTEM
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COCHLEAR BONE ANCHORED SOLUTIONS AB BA400 ABUTMENT 6MM; COCHLEAR BAHA CONNECT SYSTEM Back to Search Results
Model Number 93333
Medical Device Problem Code Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code Host-Tissue Reaction (1297)
Date of Event 03/02/2018
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
This report is submitted on march 19, 2018 (b)(4).
 
Event or Problem Description
Per the clinic, the patient experienced skin overgrowth at abutment site and subsequently underwent skin revision surgery to debride the area on (b)(6) 2018.The implanted device remains.
 
Additional Manufacturer Narrative
Per the clinic the patient was treated with a topical antibiotic and the patient underwent revision surgery on (b)(6) 2018.
 
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Brand Name
BA400 ABUTMENT 6MM
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 Key7347956
Report Number6000034-2018-00599
Device Sequence Number36083
Product Code MAH
UDI-Device Identifier09321502022736
UDI-Public(01)09321502022736(10)142428
Combination Product (Y/N)N
Initial Reporter StateNE
Initial Reporter CountryUS
PMA/510(K) Number
K121317
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2015
Reporter Type Manufacturer
Report Source user facility
Initial Reporter Occupation Other
Type of Report Initial,Followup
Report Date (Section B) 04/10/2018
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 Number93333
Device Catalogue Number93333
Device Lot Number142428
Was the Report Sent to FDA? No
Initial Date Received by Manufacturer 03/06/2018
Supplement Date Received by Manufacturer03/06/2018
Initial Report FDA Received Date03/18/2018
Supplement Report FDA Received Date04/30/2018
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;
Patient Age9 YR
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