• 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 Host-Tissue Reaction (1297); Edema (1820); Unspecified Infection (1930)
Event Type  Injury  
Manufacturer Narrative

Additional information was requested regarding device details; however, could not be made available as of the date of this report. Should more information be provided, a supplementary report shall be submitted. (b)(4).

 
Event Description

Per the clinic, it was reported that the patient experienced recurrent edema, skin overgrowth and infection at the abutment site. Subsequently, the patient underwent revision surgery under a general anaesthetic on (b)(6) 2018 in order to convert the patient to a subcutaneous baha implant system. During the procedure, the abutment was removed and a magnet was placed on the internal fixture.

 
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 43533
SW 43533
Manufacturer Contact
sujeewa wijesinghe
1 university avenue
macquarie university, nsw 2109
AS   2109
MDR Report Key7972524
MDR Text Key123935508
Report Number6000034-2018-02090
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
Report Date 10/08/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/16/2018
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?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/08/2018
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: 10/16/2018 Patient Sequence Number: 1
-
-