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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB BIA300 IMPLANT 4MM W ABUTMENT 6MM; COCHLEAR BAHA CONNECT SYSTEM

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COCHLEAR BONE ANCHORED SOLUTIONS AB BIA300 IMPLANT 4MM W ABUTMENT 6MM; COCHLEAR BAHA CONNECT SYSTEM Back to Search Results
Model Number 92127
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Wound Dehiscence (1154)
Event Date 07/29/2019
Event Type  Injury  
Manufacturer Narrative
(b)(4).
 
Event Description
Per the clinic, the recipient experienced an ongoing non healing wound over the site.Antibiotics treatment did not alleviate the problem.The device was explanted on (b)(6) 2019.
 
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Brand Name
BIA300 IMPLANT 4MM W ABUTMENT 6MM
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 Key8853798
MDR Text Key153060114
Report Number6000034-2019-01506
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 08/02/2019,07/11/2019
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
Device Operator Lay User/Patient
Device Model Number92127
Device Catalogue Number92127
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA08/02/2019
Distributor Facility Aware Date07/11/2019
Event Location Hospital
Initial Date Manufacturer Received Not provided
Initial Date FDA Received08/02/2019
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age72 YR
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