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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB BI300 IMPLANT 3MM COCHLEAR BAHA CONNECT SYSTEM

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COCHLEAR BONE ANCHORED SOLUTIONS AB BI300 IMPLANT 3MM COCHLEAR BAHA CONNECT SYSTEM Back to Search Results
Model Number 92128
Device Problem Patient Device Interaction Problem (4001)
Patient Problems Erythema (1840); Skin Inflammation/ Irritation (4545)
Event Date 03/31/2020
Event Type  Injury  
Event Description

Per the clinic, the patient experienced recurrent skin issues, including inflammation and erythema, at the abutment site, and was treated with topical antibiotic ointment on (b)(6)2020. However, the issue could not be resolved. A revision surgery is planned but has not yet occurred as of the date of this report.

 
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Brand NameBI300 IMPLANT 3MM
Type of DeviceCOCHLEAR 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 Key11152912
MDR Text Key226225950
Report Number6000034-2021-00194
Device Sequence Number1
Product Code LXB
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/12/2021,01/08/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/11/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL Number92128
Device Catalogue Number92128
Device LOT NumberCOH88449
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA02/12/2021
Distributor Facility Aware Date01/08/2021
Event Location No Information
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient TREATMENT DATA
Date Received: 01/11/2021 Patient Sequence Number: 1
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