KAHN UTERINE CANNULA GL2360

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2002-12-20 for KAHN UTERINE CANNULA GL2360 manufactured by Allegiance Healthcare Corporation.

Event Text Entries

[297894] Dr. States that she was performing procedure when the tip of the device broke off into the uterus. The patient was taken to the or and had the device surgically removed.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1423507-2002-00163
MDR Report Key433697
Date Received2002-12-20
Date of Report2002-12-20
Date of Event2002-11-20
Date Mfgr Received2002-11-25
Date Added to Maude2002-12-23
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
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 Location0
Manufacturer ContactPATRICIA SHARPE-GREGG
Manufacturer Street1430 WAUKEGAN ROAD
Manufacturer CityMCGAW PARK IL 60085
Manufacturer CountryUS
Manufacturer Postal60085
Manufacturer Phone8475784148
Manufacturer G1*
Manufacturer Street*
Manufacturer City*
Manufacturer Country*
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameKAHN UTERINE CANNULA
Generic NameINSTRUMENT
Product CodeHGH
Date Received2002-12-20
Model NumberGL2360
Catalog NumberGL2360
Lot NumberUNK
ID NumberUNK
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Implant FlagN
Date RemovedU
Device Sequence No1
Device Event Key422638
ManufacturerALLEGIANCE HEALTHCARE CORPORATION
Manufacturer Address1430 WAUKEGAN ROAD MCGAW PARK IL 60085 US
Baseline Brand NameKAHN UTERINE CANNULA
Baseline Generic NameINSTRUMENT
Baseline Model NoGL2360
Baseline Catalog NoGL2360
Baseline IDNA
Baseline Device FamilyINSTRUMENT
Baseline Shelf Life [Months]NA
Baseline PMA FlagN
Baseline 510K PMNN
Baseline PreamendmentY
Baseline TransitionalN
510k ExemptN


Patients

Patient NumberTreatmentOutcomeDate
10 2002-12-20

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