*

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-07-24 for * manufactured by Burkhart Roentgen International, Inc..

Event Text Entries

[67658] Received notification from the florida dept. Of health, bureau of radiation control advisory that some radiation sheilds manufactured after october 1996 used for radiation protection may contain radioactive contamination. 15 protective sheilds were found to be emitting radiation.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 108599
• MDR Report Key: 108599
• Date Received: 1997-07-24
• Date of Report: 1997-07-21
• Date of Event: 1997-07-01
• Date Facility Aware: 1997-07-01
• Report Date: 1997-07-21
• Date Reported to FDA: 1997-07-22
• Date Reported to Mfgr: 1997-07-22
• Date Added to Maude: 1997-07-30
• Event Key: 0
• Report Source Code: User Facility 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: UNKNOWN
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: *
• Generic Name: RADIATION SHEILDS
• Product Code: KPY
• Date Received: 1997-07-24
• Returned To Mfg: 1997-07-14
• 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: 1
• Device Event Key: 106734
• Manufacturer: BURKHART ROENTGEN INTERNATIONAL, INC.
• Manufacturer Address: 5201 8TH AVE. SOUTH ST. PETERSBURG FL 33707 US

Patients

Patient Number	Treatment	Outcome	Date
1	0		1997-07-24