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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB BAHA 5 SOUNDPROCESSOR, SILVER COCHLEAR BAHA CONNECT SYSTEM

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COCHLEAR BONE ANCHORED SOLUTIONS AB BAHA 5 SOUNDPROCESSOR, SILVER COCHLEAR BAHA CONNECT SYSTEM Back to Search Results
Model Number 95203
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem Unspecified Infection (1930)
Event Type  Injury  
Manufacturer Narrative

This report is submitted on 11 nov 2020.

 
Event Description

Per the clinic, the patient experienced infection around the abutment site. Revision surgery is planned but has not taken place as of the date of this report.

 
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Brand NameBAHA 5 SOUNDPROCESSOR, SILVER
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
Manufacturer (Section G)
COCHLEAR LIMITED
1 university avenue
macquarie university
nsw 2109
AS 2109
Manufacturer Contact
kristel kohne
1 university avenue
no.8 jalan kerinchi,
macqaurie university, nsw 2109
AS   2109
MDR Report Key10821248
MDR Text Key215895928
Report Number6000034-2020-03061
Device Sequence Number1
Product Code LXB
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK142907
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 01/15/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/11/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL Number95203
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/15/2021
Was Device Evaluated By Manufacturer? No
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 11/11/2020 Patient Sequence Number: 1
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