UNK

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2002-12-13 for UNK manufactured by Unk.

Event Text Entries

[299409] During d&c procedure, pt's uterus was perforated by currette. Physician used cautery on injured area.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number433405
MDR Report Key433405
Date Received2002-12-13
Date of Report2002-12-12
Date of Event2002-11-27
Date Facility Aware2002-12-06
Report Date2002-12-12
Date Reported to FDA2002-12-12
Date Added to Maude2002-12-20
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Reporter OccupationRISK MANAGER
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameUNK
Generic NameCURRETTE
Product CodeHCY
Date Received2002-12-13
Model NumberUNK
Catalog NumberUNK
Lot NumberUNK
ID NumberUNK
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeNO INFO
Implant FlagN
Date RemovedA
Device Sequence No1
Device Event Key422346
ManufacturerUNK
Manufacturer AddressUNK UNK *


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2002-12-13

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