LEAD APRON *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-06-25 for LEAD APRON * manufactured by Lite-tech, Inc..

Event Text Entries

[57979] Physicist checked devices because of a report he saw on internet. Background reading is. 02 mr per hour. Each of the protective devices he checked measured well over background from 0. 5 to 2. 0 mr per hour. He reports no urgency in removing devices from dept. Devices included: 3 lead aprons; 1 lap apron and 4 thyroid shields.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1011560
• MDR Report Key: 100374
• Date Received: 1997-06-25
• Date of Report: 1997-06-25
• Date of Event: 1997-06-17
• Date Added to Maude: 1997-06-26
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Health Professional: 3
• Initial Report to FDA: 0
• Report to FDA: 0
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Sequence Number: 1

• Brand Name: LEAD APRON
• Generic Name: LEAD APRON
• Product Code: EAJ
• Date Received: 1997-06-25
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: STYLE 610A-K
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 98887
• Manufacturer: LITE-TECH, INC.
• Manufacturer Address: 2ND & DEPOT ST. BRIDGEPORT PA 19405 US

Device Sequence Number: 2

• Brand Name: LEAD APRON
• Generic Name: LEAD APRON
• Product Code: EAJ
• Date Received: 1997-06-25
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: STYLE 610A-A
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 2
• Device Event Key: 98890
• Manufacturer: LITE-TECH, INC.
• Manufacturer Address: 2ND & DEPOT ST. BRIDGEPORT PA 19405 US

Device Sequence Number: 3

• Brand Name: LEAD APRON
• Generic Name: LEAD APRON
• Product Code: EAJ
• Date Received: 1997-06-25
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: 610A-E
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 3
• Device Event Key: 98893
• Manufacturer: LITE-TECH, INC.
• Manufacturer Address: 2ND & DEPOT ST BRIDGEPORT PA 19405 US

Device Sequence Number: 4

• Brand Name: LAP APRON
• Generic Name: LAP APRON
• Product Code: IWO
• Date Received: 1997-06-25
• Model Number: *
• Catalog Number: 640H-3
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 4
• Device Event Key: 98894
• Manufacturer: LITE-TECH, INC.
• Manufacturer Address: 2ND & DEPOT ST. BRIDGEPORT PA 19405 US

Device Sequence Number: 5

• Brand Name: THYROID SHIELD
• Generic Name: THYROID SHIELD
• Product Code: KPY
• Date Received: 1997-06-25
• Model Number: *
• Catalog Number: 640T
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 5
• Device Event Key: 98896
• Manufacturer: LITE-TECH, INC.
• Manufacturer Address: 2ND & DEPOT ST. BRIDGEPORT PA 19405 US

Patients

Patient Number	Treatment	Outcome	Date
1	0		1997-06-25