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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 Problem Unspecified Infection (1930)
Event Date 01/07/2019
Event Type  Injury  
Event Description
Per the clinic, the patient developed granulation tissue at the abutment site which was treated with silver nitrate on (b)(6) 2019.However, the patient developed an infection at the abutment site beginning in (b)(6) 2019, and was treated with a topical antibiotic ointment on (b)(6) 2019.Due to skin overgrowth on the abutment, the patient underwent a revision surgery on (b)(6) 2020, to change the abutment, and was treated with a steroid injection and topical antibiotic ointment.The implanted device remains.
 
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Brand Name
BI300 IMPLANT 3MM
Type of Device
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 Key11152637
MDR Text Key226226885
Report Number6000034-2021-00192
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 Other
Type of Report Initial
Report Date 01/12/2021,12/21/2020
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
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/12/2021
Distributor Facility Aware Date12/21/2020
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age10 YR
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