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 Number: MW1012477
• MDR Report Key: 133156
• Date Received: 1997-11-17
• Date of Report: 1997-11-17
• Date of Event: 1997-07-01
• Date Added to Maude: 1997-11-20
• 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: RADIOLOGIC TECHNOLOGIST
• 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: LITE-TECH
• Generic Name: LEAD APRON
• Product Code: EAJ
• Date Received: 1997-11-17
• 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: 130147
• Manufacturer: LITE-TECH INC.
• Manufacturer Address: 2ND & DEPOT ST. BRIDGEPORT PA 19405 US

Device Sequence Number: 2

• Brand Name: LITE-TECH
• Generic Name: LEAD SHIELD
• Product Code: KPY
• Date Received: 1997-11-17
• Model Number: UNK
• Catalog Number: UNK
• Lot Number: UNK
• ID Number: UNK
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: UNKNOWN
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 2
• Device Event Key: 130148
• Manufacturer: LITE-TECH INC.
• Manufacturer Address: 2ND & DEPOT ST. BRIDGEPORT PA 19405 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1997-11-17