E-Z-EM * AF95K

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-12-08 for E-Z-EM * AF95K manufactured by E-z-em, Inc..

Event Text Entries

[16819830] Facility purchased 5 lead aprons from e-z-em in may. In october they notified user of the possible contamination. Each of the aprons tested positive for contamination. Approx 53 hlth care professionals rec'd varying amounts of exposures of these aprons.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 138305
• MDR Report Key: 138305
• Date Received: 1997-12-08
• Date of Report: 1997-12-05
• Date Facility Aware: 1997-10-01
• Report Date: 1997-12-05
• Date Reported to FDA: 1997-12-05
• Date Added to Maude: 1997-12-18
• 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
• 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 Sequence Number: 1

• Brand Name: E-Z-EM
• Generic Name: LEAD PROTECTIVE PRODUCTS
• Product Code: EAJ
• Date Received: 1997-12-08
• Returned To Mfg: 1997-12-08
• Model Number: *
• Catalog Number: AF95K
• Lot Number: 134
• ID Number: 36 X 24
• Operator: HEALTH PROFESSIONAL
• Device Availability: R
• Device Age: 5 MO
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 135064
• Manufacturer: E-Z-EM, INC.
• Manufacturer Address: 717 MAIN ST. WESTBURY NY 115905021 US

Device Sequence Number: 2

• Brand Name: E-Z-EM
• Generic Name: LEAD PROTECTIVE PRODUCTS
• Product Code: EAJ
• Date Received: 1997-12-08
• Returned To Mfg: 1997-12-08
• Model Number: *
• Catalog Number: AF95K
• Lot Number: 134
• ID Number: 36 X 24
• Operator: HEALTH PROFESSIONAL
• Device Availability: R
• Device Age: 5 MO
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 2
• Device Event Key: 135065
• Manufacturer: E-Z-EM, INC.
• Manufacturer Address: 717 MAIN ST. WESTBURY NY 115905021 US

Device Sequence Number: 3

• Brand Name: E-Z-EM
• Generic Name: LEAD PROTECTIVE PRODUCTS
• Product Code: EAJ
• Date Received: 1997-12-08
• Returned To Mfg: 1997-12-08
• Model Number: *
• Catalog Number: AF95K
• Lot Number: 134
• ID Number: 36 X 24
• Operator: HEALTH PROFESSIONAL
• Device Availability: R
• Device Age: 5 MO
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 3
• Device Event Key: 135069
• Manufacturer: E-Z-EM, INC.
• Manufacturer Address: 717 MAIN ST. WESTBURY NY 115905021 US

Device Sequence Number: 4

• Brand Name: E-Z-EM
• Generic Name: LEAD PROTECTIVE PRODUCTS
• Product Code: EAJ
• Date Received: 1997-12-08
• Returned To Mfg: 1997-12-08
• Model Number: *
• Catalog Number: 258165
• Lot Number: 134
• ID Number: 16 X 20
• Operator: HEALTH PROFESSIONAL
• Device Availability: R
• Device Age: 5 MO
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 4
• Device Event Key: 135071
• Manufacturer: E-Z-EM, INC.
• Manufacturer Address: 717 MAIN ST. WESTBURY NY 11591 US

Device Sequence Number: 5

• Brand Name: E-Z-EM
• Generic Name: LEAD PROTECTIVE PRODUCTS
• Product Code: EAJ
• Date Received: 1997-12-08
• Returned To Mfg: 1997-12-08
• Model Number: *
• Catalog Number: AF95S
• Lot Number: 116
• ID Number: 42 X 24
• Operator: HEALTH PROFESSIONAL
• Device Availability: R
• Device Age: 5 MO
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 5
• Device Event Key: 135072
• Manufacturer: E-Z-EM, INC.
• Manufacturer Address: 717 MAIN ST. WESTBURY NY 115905021 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1997-12-08