UNKNOWN

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2007-08-14 for UNKNOWN manufactured by Unk.

Event Text Entries

[675087] Tip of #4 curette surgical instrument dislodged from handle in uterus during surgical procedure.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number898842
MDR Report Key898842
Report Source99
Date Received2007-08-14
Date of Report2007-08-07
Date of Event2007-08-03
Date Facility Aware2007-08-03
Report Date2007-08-13
Date Reported to FDA2007-08-13
Date Added to Maude2007-08-24
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use0
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameUNKNOWN
Generic Name#4 CURETTE
Product CodeHCY
Date Received2007-08-14
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeNA
Device Eval'ed by Mfgr*
Implant FlagN
Date RemovedB
Device Sequence No1
Device Event Key876494
ManufacturerUNK
Manufacturer AddressUNK UNK


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2007-08-14

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