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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 Discharge (2225); Skin Inflammation (2443); Patient Problem/Medical Problem (2688)
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
This report is submitted on jul 3, 2020.
 
Event or Problem Description
Per the clinic, the patient experienced skin irritation which was successfully treated with oral and topical antibiotics.
 
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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 Key10228787
Report Number6000034-2020-01681
Device Sequence Number14238802
Product Code MAH
UDI-Device Identifier09321502022385
UDI-Public(01)09321502022385(10)COH904078
Combination Product (Y/N)N
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2016
Reporter Type Importer
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 06/12/2020
Report Date (Section F) 07/03/2020
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 NumberCOH904078
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Date Report to Manufacturer06/12/2020
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date07/03/2020
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 FDA07/03/2020
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