* 253371

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-09-25 for * 253371 manufactured by E-z-em, Inc..

Event Text Entries

[17900349] After notification that lead aprons contained contaminated lead, a total of three aprons were removed to a storage area away from pt and employee contact. The aprons were packaged per e-z-em instructions, in a sealed cardboard box with two green shipping labels on the exterior of box. The sealed box was then placed in another cardboard box with white shipping labels affixed to the exterior. The package was surveyed to ensure it did not exceed 0. 5mr/hr. The package was placed in the storage area until the shipment date of july 11, 1997.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1012173
• MDR Report Key: 122765
• Date Received: 1997-09-25
• Date of Report: 1997-09-25
• Date Added to Maude: 1997-09-30
• 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: RISK MANAGER
• 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: *
• Generic Name: LEAD APRON
• Product Code: EAJ
• Date Received: 1997-09-25
• Model Number: *
• Catalog Number: 253371
• Lot Number: 129, 131
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 120231
• Manufacturer: E-Z-EM, INC.
• Manufacturer Address: 717 MAIN ST WESTBURY NY 11590 US

Device Sequence Number: 2

• Brand Name: *
• Generic Name: LEAD APRON
• Product Code: EAJ
• Date Received: 1997-09-25
• Model Number: *
• Catalog Number: 258895
• Lot Number: 134
• ID Number: *
• Device Availability: *
• Device Age: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 2
• Device Event Key: 123438
• Manufacturer: EZ-EM,INC.
• Manufacturer Address: 717 MAIN ST. WESTBURY NY 11590 US

Patients

Patient Number	Treatment	Outcome	Date
1	0		1997-09-25