TRIAD LUBRICATING JELLY *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-09-20 for TRIAD LUBRICATING JELLY * manufactured by Triad Group.

Event Text Entries

[19054569] Sterile lubricating jelly used in or. Staff was squeezing it out, and a dead mosquito came with it.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number930497
MDR Report Key930497
Date Received2007-09-20
Date of Report2007-09-20
Date of Event2007-02-07
Report Date2007-09-20
Date Reported to FDA2007-09-20
Date Added to Maude2007-10-23
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 NameTRIAD LUBRICATING JELLY
Generic NameLUBRICATING JELLY
Product CodeKMJ
Date Received2007-09-20
Model Number*
Catalog Number*
Lot Number6J02EXP09 08
ID Number*
OperatorNURSE
Device AvailabilityY
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key902650
ManufacturerTRIAD GROUP
Manufacturer Address19355 JANACEK COURT BROOKFIELD WI 53045 US


Patients

Patient NumberTreatmentOutcomeDate
10 2007-09-20

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