*

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-09-15 for * manufactured by *.

Event Text Entries

[21721581] Hysteroscopy fluid deficit.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number4293450
MDR Report Key4293450
Date Received2014-09-15
Date of Report2014-09-15
Date of Event2014-08-29
Report Date2014-09-15
Date Reported to FDA2014-09-15
Date Reported to Mfgr2014-12-03
Date Added to Maude2014-12-03
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 Code0
Event Type3
Type of Report3

Device Details

Brand Name*
Generic NameHYSTEROSCOPY FLUID
Product CodeLTA
Date Received2014-09-15
Model Number*
Catalog Number*
Lot Number*
ID Number*
Device AvailabilityN
Device Sequence No1
Device Event Key0
Manufacturer*
Manufacturer Address* * *


Patients

Patient NumberTreatmentOutcomeDate
10 2014-09-15

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