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 1998-02-10 for LEAD APRON * manufactured by Burlington Medical Supply Inc..

Event Text Entries

[93117] Contaminated lead aprons were sent to mfr for eval. Substitutes were provided by mfr until devices are returned. There are no anticipated adverse effects from the radiation.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1012963
• MDR Report Key: 148064
• Date Received: 1998-02-10
• Date of Report: 1998-02-10
• Date of Event: 1997-06-13
• Date Added to Maude: 1998-02-12
• 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: 1998-02-10
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: R
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 144278
• Manufacturer: BURLINGTON MEDICAL SUPPLY INC.
• Manufacturer Address: 3 ELMHURST DR. NEWPORT NEWS VA 23603 US

Device Sequence Number: 2

• Brand Name: LEAD APRON
• Generic Name: LEAD APRON
• Product Code: EAJ
• Date Received: 1998-02-10
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: R
• Device Age: UNKNOWN
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 2
• Device Event Key: 144280
• Manufacturer: BURLINGTON MEDICAL SUPPLY INC.
• Manufacturer Address: 3 ELMHURST DR. NEWPORT NEWS VA 23603 US

Device Sequence Number: 3

• Brand Name: LEAD APRON
• Generic Name: LEAD APRON
• Product Code: EAJ
• Date Received: 1998-02-10
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: R
• Device Age: UNKNOWN
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 3
• Device Event Key: 144282
• Manufacturer: BURLINGTON MEDICAL SUPPLY INC.
• Manufacturer Address: 3 ELMHURST DR. NEWPORT NEWS VA 23603 US

Device Sequence Number: 4

• Brand Name: LEAD APRON
• Generic Name: LEAD APRON
• Product Code: EAJ
• Date Received: 1998-02-10
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: R
• Device Age: UNKNOWN
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 4
• Device Event Key: 144284
• Manufacturer: BURLINGTON MEDICAL SUPPLY INC.
• Manufacturer Address: 3 ELMHURST DR. NEWPORT NEWS VA 23603 US

Device Sequence Number: 5

• Brand Name: LEAD APRON
• Generic Name: LEAD APRON
• Product Code: EAJ
• Date Received: 1998-02-10
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: R
• Device Age: UNKNOWN
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 5
• Device Event Key: 144285
• Manufacturer: BURLINGTON MEDICAL SUPPLY INC.
• Manufacturer Address: 3 ELMHURST DR. NEWPORT NEWS VA 23603 US

Device Sequence Number: 6

• Brand Name: LEAD APRON
• Generic Name: LEAD APRON
• Product Code: EAJ
• Date Received: 1998-02-10
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: R
• Device Age: UNKNOWN
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 6
• Device Event Key: 144286
• Manufacturer: BURLINGTON MEDICAL SUPPLY INC.
• Manufacturer Address: 3 ELMHURST DR. NEWPORT NEWS VA 23603 US

Device Sequence Number: 7

• Brand Name: LEAD APRON
• Generic Name: LEAD APRON
• Product Code: EAJ
• Date Received: 1998-02-10
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: R
• Device Age: UNKNOWN
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 7
• Device Event Key: 144287
• Manufacturer: BURLINGTON MEDICAL SUPPLY INC.
• Manufacturer Address: 3 ELMHURST DR. NEWPORT NEWS VA 23603 US

Device Sequence Number: 8

• Brand Name: LEAD APRON
• Generic Name: LEAD APRON
• Product Code: EAJ
• Date Received: 1998-02-10
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: R
• Device Age: UNKNOWN
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 8
• Device Event Key: 144288
• Manufacturer: BURLINGTON MEDICAL SUPPLY INC.
• Manufacturer Address: 3 ELMHURST DR. NEWPORT NEWS VA 23603 US

Patients

Patient Number	Treatment	Outcome	Date
1	0		1998-02-10