LEAD APRON UNK

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-09-16 for LEAD APRON UNK manufactured by Lite Tech.

Event Text Entries

[78800] Aprons are contaminated. Geiger counter readings were between. 5-1 mr/hr.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1012089
• MDR Report Key: 120070
• Date Received: 1997-09-16
• Date of Report: 1997-09-16
• Date of Event: 1997-09-16
• Date Added to Maude: 1997-09-17
• 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
• Reporter Occupation: PHYSICIST
• 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: 1997-09-16
• Model Number: UNK
• Catalog Number: UNK
• Lot Number: UNK
• ID Number: UNK
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 117706
• Manufacturer: LITE TECH
• Manufacturer Address: 2ND AND DEPOT ST. BRIDGEPORT PA 19405 US

Device Sequence Number: 2

• Brand Name: LEAD APRON
• Generic Name: LEAD APRON
• Product Code: EAJ
• Date Received: 1997-09-16
• Model Number: UNK
• Catalog Number: UNK
• Lot Number: UNK
• ID Number: UNK
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: *
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 2
• Device Event Key: 117709
• Manufacturer: LITE TECH
• Manufacturer Address: 2ND AND DEPOT ST. BRIDGEPORT PA 19405 US

Device Sequence Number: 3

• Brand Name: LEAD APRON
• Generic Name: LEAD APRON
• Product Code: EAJ
• Date Received: 1997-09-16
• Model Number: UNK
• Catalog Number: UNK
• Lot Number: UNK
• ID Number: UNK
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: *
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 3
• Device Event Key: 117710
• Manufacturer: LITE TECH
• Manufacturer Address: 2ND AND DEPOT ST BRIDGPORT PA 19405 US

Device Sequence Number: 4

• Brand Name: LEAD APRON
• Generic Name: LEAD APRON
• Product Code: EAJ
• Date Received: 1997-09-16
• Model Number: UNK
• Catalog Number: UNK
• Lot Number: UNK
• ID Number: UNK
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: *
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 4
• Device Event Key: 117711
• Manufacturer: LITE TECH
• Manufacturer Address: 2ND AND DEPOT ST. BRIDGEPORT PA 19405 US

Device Sequence Number: 5

• Brand Name: LEAD APRON
• Generic Name: LEAD APRON
• Product Code: EAJ
• Date Received: 1997-09-16
• Model Number: UNK
• Catalog Number: UNK
• Lot Number: UNK
• ID Number: UNK
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: *
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 5
• Device Event Key: 117712
• Manufacturer: LITE TECH
• Manufacturer Address: 2ND AND DEPOT ST. BRIDGEPORT PA 19405 US

Device Sequence Number: 6

• Brand Name: LEAD APRON
• Generic Name: LEAD APRON
• Product Code: EAJ
• Date Received: 1997-09-16
• Model Number: UNK
• Catalog Number: UNK
• Lot Number: UNK
• ID Number: UNK
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: *
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 6
• Device Event Key: 117714
• Manufacturer: LITE TECH
• Manufacturer Address: 2ND AND DEPOT ST. BRIDGEPORT PA 19405 US

Device Sequence Number: 7

• Brand Name: LEAD APRON
• Generic Name: LEAD APRON
• Product Code: EAJ
• Date Received: 1997-09-16
• Model Number: UNK
• Catalog Number: UNK
• Lot Number: UNK
• ID Number: UNK
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: *
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 7
• Device Event Key: 117716
• Manufacturer: LITE TECH
• Manufacturer Address: 2ND AND DEPOT ST. BRIDGEPORT PA 19405 US

Device Sequence Number: 8

• Brand Name: LEAD APRON
• Generic Name: LEAD APRON
• Product Code: EAJ
• Date Received: 1997-09-16
• Model Number: UNK
• Catalog Number: UNK
• Lot Number: UNK
• ID Number: UNK
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: *
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 8
• Device Event Key: 117717
• Manufacturer: LITE TECH
• Manufacturer Address: 2ND AND DEPOT ST. BRIDGEPORT PA 19405 US

Device Sequence Number: 9

• Brand Name: LEAD APRON
• Generic Name: LEAD APRON
• Product Code: EAJ
• Date Received: 1997-09-16
• Model Number: UNK
• Catalog Number: UNK
• Lot Number: UNK
• ID Number: UNK
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: *
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 9
• Device Event Key: 117719
• Manufacturer: LITE TECH
• Manufacturer Address: 2ND AND DEPOT ST. BRIDGEPORT PA 19405 US

Device Sequence Number: 10

• Brand Name: LEAD APRON
• Generic Name: LEAD APRON
• Product Code: EAJ
• Date Received: 1997-09-16
• Model Number: UNK
• Catalog Number: UNK
• Lot Number: UNK
• ID Number: UNK
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: *
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 10
• Device Event Key: 117720
• Manufacturer: LITE TECH
• Manufacturer Address: 2ND AND DEPOT ST. BRIDGEPORT PA 19405 US

Patients

Patient Number	Treatment	Outcome	Date
1	0		1997-09-16