• 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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Skin Infection (4544); Skin Inflammation/ Irritation (4545)
Event Date 11/11/2020
Event Type  Injury  
Event Description
Per the clinic, the patient developed an infection and recurrent inflammation at the abutment site, and was treated with topical and oral antibiotics, and topical steroid creams.The patient was placed under general anesthesia on (b)(6) 2020, in order to remove the abutment and close the wound.The implanted device remains.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
ASKU
Type of Device
COCHLEAR BAHA CONNECT SYSTEM
Manufacturer (Section D)
COCHLEAR BONE ANCHORED SOLUTIONS AB
konstruktionsvägen 14
po box 82
mölnlycke, 435 2 2
SW  435 22
MDR Report Key10999563
MDR Text Key221228234
Report Number6000034-2020-03424
Device Sequence Number1
Product Code LXB
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation Other
Type of Report Initial
Report Date 12/14/2020,11/24/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/13/2020
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
Was the Report Sent to FDA? Yes
Date Report Sent to FDA12/14/2020
Distributor Facility Aware Date11/24/2020
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age6 YR
-
-