T-COAT MICRO HDL KERR RONG THIN 8IN 1MM NL4252-81T

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-05-21 for T-COAT MICRO HDL KERR RONG THIN 8IN 1MM NL4252-81T manufactured by Carefusion, Inc.

Event Text Entries

[109374230] (b)(4) on (b)(4) 2018 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.
Patient Sequence No: 1, Text Type: N, H10


[109374231] Via phone conversation: jaw has broken. Additional information received via email on (b)(6) 2018: the date of use was actually 2 different dates. One was on tuesday (b)(6) 2018, and the other on (b)(6) 2018. The kerrisons did break while we were using them in patient? S necks. There was luckily no harm to the patient or the doctor. Both of the kerrisons that we recently ordered have broken. Lot numbers- c17xme and l17xme. On (b)(6) 2018 additional information: patient information: (age, gender, weight) one male, (b)(6), bmi 34. One female, (b)(6), bmi 30. Was there any patient medical intervention? No. What was the patient? S medical status after the event? Stable. Did any part of the device break/fall into the patient? S body field? Yes, the broken piece of the jaw fell into the neck. If yes how was the object retrieved? With the suction and forceps. Did the patient require an additional medical procedure such as an x-ray? No. How was the event resolved, was the device removed from use and replaced with another? Kerrisons were removed from our sets, and now we have two sets down that are incomplete. What type of procedure was being performed? They were both acdf's. Was the procedure completed as planned? Yes. Has your facility reported the event to the fda? No. No further information available.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1423507-2018-00007
MDR Report Key7529583
Date Received2018-05-21
Date of Report2018-06-05
Date of Event2018-04-10
Date Mfgr Received2018-05-01
Date Added to Maude2018-05-21
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactBDX ANNA WEHRHEIM
Manufacturer Street75 N. FAIRVIEW DRIVE
Manufacturer CityVERNON HILLS IL 60061
Manufacturer CountryUS
Manufacturer Postal60061
Manufacturer G1CAREFUSION, INC
Manufacturer Street75 N. FAIRVIEW DRIVE
Manufacturer CityVERNON HILLS IL 60061
Manufacturer CountryUS
Manufacturer Postal Code60061
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameT-COAT MICRO HDL KERR RONG THIN 8IN 1MM
Generic NameKERRISON RONGEURS
Product CodeHAE
Date Received2018-05-21
Catalog NumberNL4252-81T
Lot NumberC17XME
OperatorPHYSICIAN
Device Availability*
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerCAREFUSION, INC
Manufacturer Address75 N. FAIRVIEW DRIVE VERNON HILLS IL 60061 US 60061


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2018-05-21

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