LEADCARE ULTRA CONSUMABLES 70-8098

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-10-21 for LEADCARE ULTRA CONSUMABLES 70-8098 manufactured by Magellan Diagnostics, Inc..

MAUDE Entry Details

• Report Number: 1218996-2019-00038
• MDR Report Key: 9213357
• Report Source: HEALTH PROFESSIONAL
• Date Received: 2019-10-21
• Date of Report: 2019-10-21
• Date of Event: 2014-10-22
• Date Mfgr Received: 2014-10-23
• Device Manufacturer Date: 2014-06-03
• Date Added to Maude: 2019-10-21
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: MS. IVY MARGARET THIONG'O
• Manufacturer Street: 101 BILLERICA AVE BUILDING 4
• Manufacturer City: N. BILLERICA MA 01862
• Manufacturer Country: US
• Manufacturer Postal: 01862
• Manufacturer Phone: 9783135480
• Manufacturer G1: MAGELLAN DIAGNOSTICS, INC.
• Manufacturer Street: 101 BILLERICA AVE BUILDING 4
• Manufacturer City: N. BILLERICA MA 01862
• Manufacturer Country: US
• Manufacturer Postal Code: 01862
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: LEADCARE ULTRA CONSUMABLES
• Generic Name: LEADCARE ULTRA
• Product Code: DOF
• Date Received: 2019-10-21
• Returned To Mfg: 2014-11-17
• Model Number: LEADCARE ULTRA
• Catalog Number: 70-8098
• Lot Number: 1312BU
• Device Expiration Date: 2015-06-30
• Operator: HEALTH PROFESSIONAL
• Device Availability: R
• Device Eval'ed by Mfgr: Y
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: MAGELLAN DIAGNOSTICS, INC.
• Manufacturer Address: 101 BILLERICA AVE BUILDING 4 N. BILLERICA MA 01826 US 01826

Patients

Patient Number	Treatment	Outcome	Date
1	0		2019-10-21