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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION, INC -COAT MICRO HDL KERR RONG THIN 8IN 3MM KERRISON RONGEURS

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CAREFUSION, INC -COAT MICRO HDL KERR RONG THIN 8IN 3MM KERRISON RONGEURS Back to Search Results
Catalog Number NL4252-83T
Device Problem Break (1069)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/26/2019
Event Type  malfunction  
Manufacturer Narrative
On 09sep2019 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
The following was reported via email: dr (b)(6) was using a 3mm kerrison on his lumbar fusion yesterday and the foot plate broke. All the pieces were removed from the patient. No further information available.
 
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Brand Name-COAT MICRO HDL KERR RONG THIN 8IN 3MM
Type of DeviceKERRISON RONGEURS
Manufacturer (Section D)
CAREFUSION, INC
75 north fairway drive
vernon hills IL 60061
Manufacturer (Section G)
CAREFUSION, INC
75 north fairway drive
vernon hills IL 60061
Manufacturer Contact
anna wehrheim
75 north fairway drive
vernon hills, IL 60061
8015652341
MDR Report Key9081066
MDR Text Key164592116
Report Number1423507-2019-00013
Device Sequence Number1
Product Code HAE
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
PREAMENDMENT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 10/25/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/18/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberNL4252-83T
Device Lot NumberXMEI 05
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/27/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/01/2008
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: 09/18/2019 Patient Sequence Number: 1
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