BRUNS CURETTE OVAL ANG CUP SZ 0000 9IN NL6760

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2011-12-28 for BRUNS CURETTE OVAL ANG CUP SZ 0000 9IN NL6760 manufactured by Carefusion.

Event Text Entries

[2499149] Broken the curette tip broke off during total right knee arthroplasty.? The tip of the curette sucked into suction container.? There was no harm to the patient.
Patient Sequence No: 1, Text Type: D, B5


[9616451] (b)(4). The customer has indicated that the complaint sample cannot be returned to carefusion. Since the instrument is not available, an evaluation could not be performed.
Patient Sequence No: 1, Text Type: N, H10


[9739780] (b)(4). The customer indicated that they cannot release the instrument for evaluation. However, they will allow a representative to visit on-site and inspect the instrument.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1423507-2011-00020
MDR Report Key2390920
Report Source00
Date Received2011-12-28
Date of Report2011-11-29
Date of Event2011-11-11
Date Mfgr Received2011-11-29
Date Added to Maude2012-07-26
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationRISK MANAGER
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer ContactJILL RITTORNO
Manufacturer Street1500 WAUKEGAN ROAD
Manufacturer CityMCGAW PARK IL 60085
Manufacturer CountryUS
Manufacturer Postal60085
Manufacturer Phone8474737294
Manufacturer G1CAREFUSION 2200, INC
Manufacturer Street1500 WAUKEGAN ROAD
Manufacturer CityWAUKEGAN 60085785
Manufacturer CountryUS
Manufacturer Postal Code60085 7853
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameBRUNS CURETTE OVAL ANG CUP SZ 0000 9IN
Generic NameCURETTE, SURGICAL, GENERAL USE
Product CodeFZS
Date Received2011-12-28
Model NumberNL6760
Lot NumberUNKNOWN
OperatorPHYSICIAN
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerCAREFUSION
Manufacturer Address1500 WAUKEGAN ROAD MCGAW PARK IL 60085 US 60085


Patients

Patient NumberTreatmentOutcomeDate
10 2011-12-28

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