VERESS NEEDLE *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2001-12-19 for VERESS NEEDLE * manufactured by Core Dynamics.

Event Text Entries

[211347] During laparoscopic tubal ligation the right common iliac artery was punctured and the common iliac vein was torn.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number367276
MDR Report Key367276
Date Received2001-12-19
Date of Report2001-02-02
Date of Event2001-01-19
Date Facility Aware2001-01-19
Report Date2001-02-02
Date Reported to Mfgr2001-02-02
Date Added to Maude2001-12-26
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameVERESS NEEDLE
Generic NameDISPOSABLE INSUFFLATION NEEDLE
Product CodeFHO
Date Received2001-12-19
Model Number*
Catalog Number*
Lot Number0J837CT
ID NumberPART NUMBER A007.00
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeUNKNOWN
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key356399
ManufacturerCORE DYNAMICS
Manufacturer Address11222 ST. JOHNS INDUST PARKWAY JACKSONVILLE FL 32246 US


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization; 2. Life Threatening; 3. Required No Informationntervention 2001-12-19

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