N LATEX FLC KAPPA 10482437

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 2019-11-07 for N LATEX FLC KAPPA 10482437 manufactured by Siemens Healthcare Diagnostics Products Gmbh.

MAUDE Entry Details

• Report Number: 9610806-2019-00082
• MDR Report Key: 9292502
• Report Source: FOREIGN,HEALTH PROFESSIONAL,U
• Date Received: 2019-11-07
• Date of Report: 2019-11-07
• Date of Event: 2019-09-14
• Date Mfgr Received: 2019-10-16
• Date Added to Maude: 2019-11-07
• 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: CHRISTOPHER AEBIG
• Manufacturer Street: 511 BENEDICT AVE
• Manufacturer City: TARRYTOWN NY 10591
• Manufacturer Country: US
• Manufacturer Postal: 10591
• Manufacturer Phone: 9145242740
• Manufacturer G1: SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH
• Manufacturer Street: EMIL-VON-BEHRING-STR. 76
• Manufacturer City: MARBURG, D-35041
• Manufacturer Country: GM
• Manufacturer Postal Code: D-35041
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: N LATEX FLC KAPPA
• Generic Name: N LATEX FLC KAPPA
• Product Code: DFH
• Date Received: 2019-11-07
• Model Number: N LATEX FLC KAPPA
• Catalog Number: 10482437
• Lot Number: 473145
• Device Expiration Date: 2019-10-28
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Eval'ed by Mfgr: N
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH
• Manufacturer Address: EMIL-VON-BEHRING- STR. 76 MARBURG, D-35041 GM D-35041

Patients

Patient Number	Treatment	Outcome	Date
1	0		2019-11-07