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U.S. Department of Health and Human Services

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

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COCHLEAR BONE ANCHORED SOLUTIONS AB BAHA 5 SOUNDPROCESSOR, BLONDE COCHLEAR BAHA CONNECT SYSTEM Back to Search Results
Model Number 95201
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/09/2020
Event Type  Injury  
Manufacturer Narrative

This report is submitted on 03 nov 2020.

 
Event Description

Per the clinic, the abutment was electively removed under a general anaesthetic on (b)(6) 2020.

 
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Brand NameBAHA 5 SOUNDPROCESSOR, BLONDE
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
durga velayutham
unit ug-1, vertical podium
no.8 jalan kerinchi,
kuala lumpur, wilayah persekutuan 59200
MY   59200
MDR Report Key10776193
MDR Text Key214303679
Report Number6000034-2020-02975
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
Report Date 10/14/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/02/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL Number95201
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 Received10/14/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
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: 11/02/2020 Patient Sequence Number: 1
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