PILLING KNIFE HANDLE 3 352950

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2012-06-07 for PILLING KNIFE HANDLE 3 352950 manufactured by Teleflex.

Event Text Entries

[2766457] The event is reported as: customer alleges it is very difficult to blade on and off the handle. A nurse's finger got cut when she tried to remove the blade. Unk if she used a forcep, as is protocol, to remove it. This occurred before pt use.
Patient Sequence No: 1, Text Type: D, B5


[9924275] Sample has not been received by manufacturer in time for this report. A follow up report will be submitted when completed.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1044475-2012-00060
MDR Report Key2617817
Report Source05,06
Date Received2012-06-07
Date of Report2012-05-16
Date Mfgr Received2012-05-16
Date Added to Maude2012-10-05
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional0
Initial Report to FDA0
Report to FDA0
Event Location0
Manufacturer ContactELAINE BURKLE, RN
Manufacturer StreetP.O. BOX 12600
Manufacturer CityRTP NC 27709
Manufacturer CountryUS
Manufacturer Postal27709
Manufacturer Phone9194334957
Manufacturer G1TELEFLEX
Manufacturer Street2917 WECK DRIVE
Manufacturer CityRTP NC 27709
Manufacturer CountryUS
Manufacturer Postal Code27709
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NamePILLING KNIFE HANDLE 3
Generic NameKNIFE HANDLE
Product CodeGDZ
Date Received2012-06-07
Catalog Number352950
Lot NumberH29135295019
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerTELEFLEX
Manufacturer AddressRESEARCH TRIANGLE PARK NC 27709 US 27709


Patients

Patient NumberTreatmentOutcomeDate
10 2012-06-07

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