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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB BA300 ABUTMENT 9MM COCHLEAR BAHA CONNECT SYSTEM

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COCHLEAR BONE ANCHORED SOLUTIONS AB BA300 ABUTMENT 9MM COCHLEAR BAHA CONNECT SYSTEM Back to Search Results
Model Number 92131
Device Problem Patient Device Interaction Problem (4001)
Patient Problem Unspecified Infection (1930)
Event Date 05/17/2021
Event Type  Injury  
Event Description

Per the clinic, the patient experienced chronic infection at the abutment site, and was treated with oral and topical antibiotics (specific date and duration not reported). The patient was placed under a general anesthetic on (b)(6) 2021, in order to remove the abutment.

 
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Brand NameBA300 ABUTMENT 9MM
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 Key12038159
MDR Text Key257372649
Report Number6000034-2021-01955
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
Report Date 06/22/2021,02/18/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/21/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL Number92131
Device Catalogue Number92131
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/22/2021
Distributor Facility Aware Date02/18/2021
Event Location No Information
Date Report TO Manufacturer06/22/2021
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: 06/21/2021 Patient Sequence Number: 1
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