SPECTRIS SOLARIS SYRINGE KIT 85233084 SSQK 115

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 2019-11-15 for SPECTRIS SOLARIS SYRINGE KIT 85233084 SSQK 115 manufactured by Bayer Medical Care Inc..

MAUDE Entry Details

• Report Number: 2520313-2019-00054
• MDR Report Key: 9327511
• Report Source: COMPANY REPRESENTATIVE,HEALTH
• Date Received: 2019-11-15
• Date of Report: 2019-11-15
• Date of Event: 2019-11-07
• Date Mfgr Received: 2019-11-07
• Device Manufacturer Date: 2019-08-07
• Date Added to Maude: 2019-11-15
• 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. LOIS MILLER
• Manufacturer Street: ONE BAYER DRIVE
• Manufacturer City: INDIANOLA PA 15051
• Manufacturer Country: US
• Manufacturer Postal: 15051
• Manufacturer Phone: 7249407497
• Manufacturer G1: BAYER MEDICAL CARE INC.
• Manufacturer Street: ONE 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: SPECTRIS SOLARIS SYRINGE KIT
• Generic Name: ANGIOGRAPHIC SYRINGE KIT
• Product Code: DXT
• Date Received: 2019-11-15
• Model Number: 85233084
• Catalog Number: SSQK 115
• Lot Number: 8411737
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Eval'ed by Mfgr: R
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: BAYER MEDICAL CARE INC.
• Manufacturer Address: ONE BAYER DRIVE INDIANOLA PA 15051 US 15051

Patients

Patient Number	Treatment	Outcome	Date
1	0		2019-11-15