PILLING CORONARY SCISSORS 7" 352165

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,08 report with the FDA on 2010-03-15 for PILLING CORONARY SCISSORS 7" 352165 manufactured by Teleflex Medical.

Event Text Entries

[14868325] The event is reported as: the device has a rough square finish to the tips. It was reported that the device was not used during a medical procedure or during treatment. No patient injury reported.
Patient Sequence No: 1, Text Type: D, B5


[15521049] The device sample is not available for evaluation. The results of the investigation are not available at the time of this report.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1044475-2010-00016
MDR Report Key1639343
Report Source01,08
Date Received2010-03-15
Date of Report2010-02-23
Date of Event2010-02-10
Date Mfgr Received2010-02-23
Date Added to Maude2010-12-13
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 FDA0
Event Location0
Manufacturer ContactANGELA BROWN, MANAGER
Manufacturer StreetP.O. BOX 12600
Manufacturer CityRTP NC 27709
Manufacturer CountryUS
Manufacturer Postal27709
Manufacturer Phone9194334901
Manufacturer G1TELEFLEX MEDICAL
Manufacturer Street2917 WECK DR.
Manufacturer CityRTP NC 27709
Manufacturer CountryUS
Manufacturer Postal Code27709
Single Use3
Remedial ActionOT
Previous Use Code3
Removal Correction NumberNA
Event Type3
Type of Report3

Device Details

Brand NamePILLING CORONARY SCISSORS 7"
Generic NameCORONARY SCISSORS
Product CodeLRR
Date Received2010-03-15
Model NumberNA
Catalog Number352165
Lot NumberRR2
ID NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerTELEFLEX MEDICAL
Manufacturer AddressRTP NC US


Patients

Patient NumberTreatmentOutcomeDate
10 2010-03-15

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