HEMOLOK REMOVER XL/L 544130

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2010-04-20 for HEMOLOK REMOVER XL/L 544130 manufactured by Teleflex Medical.

Event Text Entries

[16737871] The event is reported as: surgeon is having difficulty removing clips with device. No reported pt injury.
Patient Sequence No: 1, Text Type: D, B5


[17009166] Sample has not been returned for investigation. The investigation is not complete at the time of this report. A follow up investigation report will be sent when completed.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1044475-2010-00048
MDR Report Key1675329
Report Source06,07
Date Received2010-04-20
Date of Report2010-03-30
Date of Event2010-03-30
Date Mfgr Received2010-03-30
Date Added to Maude2010-10-25
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 NameHEMOLOK REMOVER XL/L
Generic NameCLIP REMOVER
Product CodeHBQ
Date Received2010-04-20
Returned To Mfg2010-04-09
Model NumberNA
Catalog Number544130
Lot Number1516134-004
ID NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerTELEFLEX MEDICAL
Manufacturer AddressRTP NC 27709 US 27709


Patients

Patient NumberTreatmentOutcomeDate
10 2010-04-20

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.