COLLER CURVED HEMOSTAT 477110

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2009-10-02 for COLLER CURVED HEMOSTAT 477110 manufactured by Teleflex Medical.

Event Text Entries

[1303135] The event is reported as: the surgeon was using the curved coller forcep when a piece broke off. Broken piece (2. 5" long) was retrieved. No further problems reported. No pt injury reported. Also, received medwatch.
Patient Sequence No: 1, Text Type: D, B5


[8418508] The sample device was requested for eval. The results of investigation are not available at the time of this report.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1044475-2009-00038
MDR Report Key1518483
Report Source06
Date Received2009-10-02
Date of Report2009-09-14
Date of Event2009-09-11
Date Mfgr Received2009-09-14
Date Added to Maude2010-07-27
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, MGR
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 NameCOLLER CURVED HEMOSTAT
Generic NameCURVED HEMOSTAT
Product CodeEMD
Date Received2009-10-02
Model NumberNA
Catalog Number477110
Lot Number1-82WCGH
ID NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerTELEFLEX MEDICAL
Manufacturer AddressRTP NC 27709 US 27709


Patients

Patient NumberTreatmentOutcomeDate
10 2009-10-02

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