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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 14MM; COCHLEAR BAHA CONNECT SYSTEM
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COCHLEAR BONE ANCHORED SOLUTIONS AB BIA400 IMPLANT 4MM W ABUTMENT 14MM; COCHLEAR BAHA CONNECT SYSTEM Back to Search Results
Model Number 93338
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Post Operative Wound Infection (2446)
Date of Event 11/25/2019
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
This report is submitted on december 18, 2019.
 
Event or Problem Description
Per the clinic, the patient experienced recurrent infections at the abutment site which was treated with a antibiotic (oral and topical).The device was explanted under a general anaesthetic (b)(6) 2019.
 
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Brand Name
BIA400 IMPLANT 4MM W ABUTMENT 14MM
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 Key9493085
Report Number6000034-2019-02923
Device Sequence Number19333341
Product Code MAH
UDI-Device Identifier09321502022385
UDI-Public(01)09321502022385(10)COH584365
Combination Product (Y/N)N
Initial Reporter StateNE
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2018
Device Explanted Year2019
Reporter Type Importer
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 11/26/2019
Report Date (Section F) 12/19/2019
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 Number93338
Device Catalogue Number93338
Device Lot NumberCOH584365
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Date Report to Manufacturer11/26/2019
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date12/19/2019
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 Age11 YR
Date Report Sent to FDA12/19/2019
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