STELLANT CT SYRINGE KIT 60728737 SDS-CTP-SPK

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-10-11 for STELLANT CT SYRINGE KIT 60728737 SDS-CTP-SPK manufactured by Bayer Medical Care.

MAUDE Entry Details

• Report Number: 2520313-2019-00044
• MDR Report Key: 9180011
• Report Source: COMPANY REPRESENTATIVE,HEALTH
• Date Received: 2019-10-11
• Date of Report: 2019-10-11
• Date of Event: 2019-09-18
• Date Mfgr Received: 2019-09-20
• Device Manufacturer Date: 2019-03-03
• Date Added to Maude: 2019-10-11
• 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: SUSAN SHERWIN
• Manufacturer Street: 1 BAYER DRIVE
• Manufacturer City: INDIANOLA PA 15051
• Manufacturer Country: US
• Manufacturer Postal: 15051
• Manufacturer Phone: 7249408678
• Manufacturer G1: BAYER MEDICAL CARE, INC.
• Manufacturer Street: 1 BAYER DRIVE
• Manufacturer City: INDIANOLA PA 15051
• Manufacturer Country: US
• Manufacturer Postal Code: 15051
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: STELLANT CT SYRINGE KIT
• Generic Name: ANGIOGRAPHIC SYRINGE KIT
• Product Code: DXT
• Date Received: 2019-10-11
• Returned To Mfg: 2019-10-01
• Model Number: 60728737
• Catalog Number: SDS-CTP-SPK
• Lot Number: 8560471
• Operator: HEALTH PROFESSIONAL
• Device Availability: R
• Device Eval'ed by Mfgr: Y
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: BAYER MEDICAL CARE
• Manufacturer Address: 1 BAYER DRIVE INDIANOLA PA 15051 US 15051

Patients

Patient Number	Treatment	Outcome	Date
1	0		2019-10-11