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

MAUDE Adverse Event Report: CAREFUSION, INC TA KERRISON RONG. 8", 4MM BITE, 40 UP KERRISON RONGEURS

  • 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
 

CAREFUSION, INC TA KERRISON RONG. 8", 4MM BITE, 40 UP KERRISON RONGEURS Back to Search Results
Catalog Number NL4291-84T
Device Problems Defective Component (2292); Material Twisted/Bent (2981)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/01/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4). On 09jul2018 writer sent the customer an email acknowledging receipt of the complaint, providing the complaint tracking number and requested follow up information including as to if there was any patient impact related to this event. Writer provided contact information. Device not yet evaluated, if the device is evaluated a follow up will be sent.
 
Event Description
Via email: instrument was defective. On 18jul2018 additional information: was the product received in this condition? no. If not, what was the product being used for when it was observed that the instrument was defective? being used in surgery. Please confirm whether there was any patient impact. Delay in case, but no injury to the patient. What exactly is wrong with the instrument? bending in the shaft. On 19jul2018 additional information: the case was delayed 5-10 minutes. No further information available.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameTA KERRISON RONG. 8", 4MM BITE, 40 UP
Type of DeviceKERRISON RONGEURS
Manufacturer (Section D)
CAREFUSION, INC
75 n. fairview drive
vernon hills IL 60061
Manufacturer (Section G)
CAREFUSION, INC
75 n. fairview drive
vernon hills IL 60061
Manufacturer Contact
anna wehrheim
75 n. fairview drive
vernon hills, IL 60061
MDR Report Key7746660
MDR Text Key116537748
Report Number1423507-2018-00015
Device Sequence Number0
Product Code HAE
Reporter Country CodeUS
PMA/PMN Number
PREAMENDMENT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other,user facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/29/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/03/2018
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberNL4291-84T
Device Lot NumberD17XME
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/29/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/01/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 08/03/2018 Patient Sequence Number: 1
-
-