SECURACATH SCR-01 400120

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2019-06-21 for SECURACATH SCR-01 400120 manufactured by Interrad Medical.

MAUDE Entry Details

• Report Number: 3007795799-2019-00003
• MDR Report Key: 8724637
• Report Source: USER FACILITY
• Date Received: 2019-06-21
• Date of Report: 2019-06-21
• Date of Event: 2019-03-28
• Date Mfgr Received: 2019-04-18
• Device Manufacturer Date: 2018-10-31
• Date Added to Maude: 2019-06-21
• 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
• Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: BRIAN BOSCH
• Manufacturer Street: 181 CHESHIRE LANE SUITE 100
• Manufacturer City: PLYMOUTH MN 554415468
• Manufacturer Country: US
• Manufacturer Postal: 554415468
• Manufacturer Phone: 7634522747
• Manufacturer G1: INTERRAD MEDICAL
• Manufacturer Street: 181 CHESHIRE LANE SUITE 100
• Manufacturer City: PLYMOUTH MN 554415468
• Manufacturer Country: US
• Manufacturer Postal Code: 554415468
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: SECURACATH
• Generic Name: SUBCUTANEOUS ENGINEERED STABILIZATION DEVICE
• Product Code: OKC
• Date Received: 2019-06-21
• Returned To Mfg: 2019-04-30
• Model Number: SCR-01
• Catalog Number: 400120
• Lot Number: A1850
• Operator: HEALTH PROFESSIONAL
• Device Availability: R
• Device Eval'ed by Mfgr: Y
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: INTERRAD MEDICAL
• Manufacturer Address: 181 CHESHIRE LANE SUITE 100 PLYMOUTH MN 554415468 US 554415468

Patients

Patient Number	Treatment	Outcome	Date
1	0		2019-06-21