LITE-TECH UNK

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-11-17 for LITE-TECH UNK manufactured by Lite-tech Inc..

Event Text Entries

[74052] Lead apron was contaminated.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW1012477
MDR Report Key133156
Date Received1997-11-17
Date of Report1997-11-17
Date of Event1997-07-01
Date Added to Maude1997-11-20
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Reporter OccupationRADIOLOGIC TECHNOLOGIST
Health Professional3
Initial Report to FDA0
Report to FDA0
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Sequence Number: 1

Brand NameLITE-TECH
Generic NameLEAD APRON
Product CodeEAJ
Date Received1997-11-17
Model NumberUNK
Catalog NumberUNK
Lot NumberUNK
ID NumberUNK
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Implant FlagN
Date RemovedA
Device Sequence No1
Device Event Key130147
ManufacturerLITE-TECH INC.
Manufacturer Address2ND & DEPOT ST. BRIDGEPORT PA 19405 US

Device Sequence Number: 2

Brand NameLITE-TECH
Generic NameLEAD SHIELD
Product CodeKPY
Date Received1997-11-17
Model NumberUNK
Catalog NumberUNK
Lot NumberUNK
ID NumberUNK
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeUNKNOWN
Implant FlagN
Date RemovedA
Device Sequence No2
Device Event Key130148
ManufacturerLITE-TECH INC.
Manufacturer Address2ND & DEPOT ST. BRIDGEPORT PA 19405 US


Patients

Patient NumberTreatmentOutcomeDate
101. Other 1997-11-17

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