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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 Patient Problem/Medical Problem (2688)
Event Date 09/06/2019
Event Type  Injury  
Event Description

Per the clinic, it was reported that the patient experienced skin overgrowth at the implant site. Topical ointment was applied to the site; however, the issue did not resolve. Subsequently, the patient underwent revision surgery on (b)(6) 2019, in order to excise excess skin and place a longer abutment.

 
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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 Key9170033
MDR Text Key161662179
Report Number6000034-2019-02078
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 PHYSICIAN ASSISTANT
Type of Report Initial
Report Date 10/09/2019,09/19/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/08/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date08/31/2019
Device MODEL Number92128
Device Catalogue Number92128
Device LOT Number162074
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA10/09/2019
Distributor Facility Aware Date09/19/2019
Event Location Hospital
Date Report TO Manufacturer10/09/2019
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: 10/08/2019 Patient Sequence Number: 1
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