• 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 BIA400 IMPLANT 4MM W ABUTMENT 12MM 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 BIA400 IMPLANT 4MM W ABUTMENT 12MM COCHLEAR BAHA CONNECT SYSTEM Back to Search Results
Model Number 93332
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problems Purulent Discharge (1812); Impaired Healing (2378)
Event Type  Injury  
Event Description

Per the clinic, the patient experienced healing issues at the implant site, resulting in purulent discharge from the site. Subsequently, the patient applied a topical antibiotic to the site and the symptoms subsided (date not reported).

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameBIA400 IMPLANT 4MM W ABUTMENT 12MM
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
MDR Report Key8978451
MDR Text Key157040117
Report Number6000034-2019-01744
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 HEALTH CARE PROFESSIONAL
Type of Report Initial
Report Date 09/10/2019,08/27/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/10/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL Number93332
Device Catalogue Number93332
Device LOT NumberASKU
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA09/10/2019
Event Location Other
Date Report TO Manufacturer09/10/2019
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient TREATMENT DATA
Date Received: 09/10/2019 Patient Sequence Number: 1
-
-