• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

COCHLEAR BONE ANCHORED SOLUTIONS AB BAHA 5 POWER SOUNDPROCESSOR, BROWN COCHLEAR BAHA CONNECT SYSTEM Back to Search Results
Model Number 95473
Device Problem Patient Device Interaction Problem (4001)
Patient Problem Unspecified Infection (1930)
Event Type  Injury  
Manufacturer Narrative

Additional information has been requested; however, not made available as of the date of this report. This report is submitted on may 20, 2020.

 
Event Description

Per the clinic, it was reported that the patient was experiencing infections under the processor.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameBAHA 5 POWER SOUNDPROCESSOR, BROWN
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 BONE ANCHORED SOLUTIONS AB
po box 82
molnlycke, 435 2 2
SW 435 22
Manufacturer Contact
bianca pries
1 university avenue
macquarie university, nsw 2109
AS   2109
MDR Report Key10073485
MDR Text Key191666566
Report Number6000034-2020-01384
Device Sequence Number1
Product Code LXB
Combination Product (Y/N)N
PMA/PMN NumberK161123
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL
Type of Report Initial
Report Date 04/27/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/19/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date12/22/2016
Device MODEL Number95473
Device Catalogue Number95473
Device LOT NumberCOH1091560
Was Device Available For Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/27/2020
Was Device Evaluated By Manufacturer? No Answer Provided
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: 05/19/2020 Patient Sequence Number: 1
-
-