• 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 ASKU 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 ASKU COCHLEAR BAHA CONNECT SYSTEM Back to Search Results
Model Number ASKU
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problems Unspecified Infection (1930); Impaired Healing (2378); Fluid Discharge (2686)
Event Date 04/02/2021
Event Type  Injury  
Manufacturer Narrative

This report is submitted on april 27, 2021.

 
Event Description

Per the clinic, the patient experienced chronic infection, healing issues, and drainage at the implant site. The device was explanted on (b)(6) 2021. The patient has not been reimplanted with a new device as of the date of this report.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameASKU
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
konstruktionsvägen 14
po box 82
mölnlycke, 435 2 2
SW 435 22
Manufacturer Contact
durga velayutham
unit ug-1, vertical podium
no.8 jalan kerinchi,
kuala lumpur, wilayah persekutuan 59200
MY   59200
MDR Report Key11730184
MDR Text Key247454623
Report Number6000034-2021-01303
Device Sequence Number1
Product Code LXB
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberASKU
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/04/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/27/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL NumberASKU
Device Catalogue NumberASKU
Device LOT NumberASKU
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/04/2021
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: 04/27/2021 Patient Sequence Number: 1
-
-