ATELLICA IM SYPHILIS (SYPH) N/A 10995675

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2019-07-19 for ATELLICA IM SYPHILIS (SYPH) N/A 10995675 manufactured by Siemens Healthcare Diagnostics, Inc..

MAUDE Entry Details

• Report Number: 1219913-2019-00134
• MDR Report Key: 8808420
• Report Source: FOREIGN,HEALTH PROFESSIONAL,U
• Date Received: 2019-07-19
• Date of Report: 2019-10-04
• Date of Event: 2019-07-01
• Date Mfgr Received: 2019-09-19
• Date Added to Maude: 2019-07-19
• 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
• Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: MS. EIMAN SULIEMAN
• Manufacturer Street: 333 CONEY STREET
• Manufacturer City: E. WALPOLE, MA 02032
• Manufacturer Country: US
• Manufacturer Postal: 02032
• Manufacturer Phone: 5086604603
• Manufacturer G1: SIEMENS HEALTHCARE DIAGNOSTICS, INC.
• Manufacturer Street: 333 CONEY STREET
• Manufacturer City: E. WALPOLE, MA 02032
• Manufacturer Country: US
• Manufacturer Postal Code: 02032
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: ATELLICA IM SYPHILIS (SYPH)
• Generic Name: SYPHILIS ASSAY
• Product Code: LIP
• Date Received: 2019-07-19
• Model Number: N/A
• Catalog Number: 10995675
• Lot Number: 63204060
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: DA
• Device Eval'ed by Mfgr: R
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: SIEMENS HEALTHCARE DIAGNOSTICS, INC.
• Manufacturer Address: 511 BENEDICT AVENUE TARRYTOWN NY 105915097 US 105915097

Patients

Patient Number	Treatment	Outcome	Date
1	0		2019-07-19