LEAD APRON * 658-P74677

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 * 658-P74677 manufactured by Burlington Medical Supplies, Inc..

Event Text Entries

[18480739] Radiology svc reports these contaminated lead shielding products: apron, wrap-around reading 0/13 mr, thyroid shield reading 0. 13 mr, apron, wrap-around reading 0. 14 mr, thyroid shield reading 0. 12 mr, apron, vest only reading 0. 14 mr, and thyroid shield reading 0. 14 mr. These items were sent back to mfr.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1012067
• MDR Report Key: 119425
• Date Received: 1997-07-18
• Date of Report: 1997-07-17
• Date of Event: 1997-05-08
• Date Added to Maude: 1997-09-16
• 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: LEAD APRON
• Generic Name: LEAD APRON
• Product Code: EAJ
• Date Received: 1997-07-18
• Model Number: *
• Catalog Number: 658-P74677
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: R
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 117087
• Manufacturer: BURLINGTON MEDICAL SUPPLIES, INC.
• Manufacturer Address: 3 ELMHURST ST. P.O. BOX 3194 NEWPORT NEWS VA 23603 US

Device Sequence Number: 2

• Brand Name: THYROID SHEILD
• Generic Name: THYROID SHIELD
• Product Code: KPY
• Date Received: 1997-07-18
• Model Number: *
• Catalog Number: 658-P74677
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: R
• Device Age: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 2
• Device Event Key: 117088
• Manufacturer: BURLINGTON MEDICAL SUPPLIES, INC.
• Manufacturer Address: 3 ELMHURST ST P.O. BOX 3194 NEWPORT NEWS VA 23603 US

Patients

Patient Number	Treatment	Outcome	Date
1	0		1997-07-18