LEAD APRON NI

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-07-18 for LEAD APRON NI manufactured by Davis Lead Aprons.

Event Text Entries

[80570] Eight lead aprons and 8 thyroid shields found to be contaminated. Has had devices since end of last year.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW1011731
MDR Report Key106317
Date Received1997-07-18
Date of Report1997-07-18
Date of Event1997-07-01
Date Added to Maude1997-07-21
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Reporter OccupationPHYSICIST
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 NameLEAD APRON
Generic NameLEAD APRON
Product CodeEAJ
Date Received1997-07-18
Model NumberNI
Catalog NumberNI
Lot NumberNI
ID NumberNI
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Implant FlagN
Date RemovedA
Device Sequence No1
Device Event Key104536
ManufacturerDAVIS LEAD APRONS
Manufacturer Address3715 ALOA ST. HOUSTON TX 77018 US

Device Sequence Number: 2

Brand NameTHYROID SHIELD
Generic NameTHYROID SHIELD
Product CodeKPY
Date Received1997-07-18
Model NumberNI
Catalog NumberNI
Lot NumberNI
ID NumberNI
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Age*
Implant FlagN
Date RemovedA
Device Sequence No2
Device Event Key104545
ManufacturerDAVIS LEAD APRONS
Manufacturer Address3715 ALOA ST. HOUSTON TX 77018 US


Patients

Patient NumberTreatmentOutcomeDate
10 1997-07-18

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