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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB BAHA 5 SUPERPOWER PROCESSING UNIT COCHLEAR BAHA CONNECT SYSTEM
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COCHLEAR BONE ANCHORED SOLUTIONS AB BAHA 5 SUPERPOWER PROCESSING UNIT COCHLEAR BAHA CONNECT SYSTEM Back to Search Results
Model Number 96003
Device Problem Use of Device Problem (1670)
Patient Problem Injury (2348)
Event Type  Injury  
Manufacturer Narrative

This report is submitted on october 15, 2019.

 
Event Description

Per the clinic, the patient developed an open wound at the implant site subsequent to wearing the external sound processor in a reverse configuration. The patient was treated with an antibiotic ointment and it was reported that the wound healed following treatment.

 
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Brand NameBAHA 5 SUPERPOWER PROCESSING UNIT
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 Contact
bianca pries
1 university avenue
macquarie university, nsw 2109
AS   2109
MDR Report Key9189358
MDR Text Key163894371
Report Number6000034-2019-02033
Device Sequence Number1
Product Code LXB
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK153245
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial
Report Date 09/25/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/14/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL Number96003
Device Catalogue Number96003
Device LOT NumberCOH1255891
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 Received09/25/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured09/06/2018
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: 10/14/2019 Patient Sequence Number: 1
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