CARDIAC CATH TRAY (CTSRF)602 SCVOCCTSRG

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2020-03-09 for CARDIAC CATH TRAY (CTSRF)602 SCVOCCTSRG manufactured by Mex03 Mexico-juarez Presource.

MAUDE Entry Details

• Report Number: 1423537-2020-00434
• MDR Report Key: 9808676
• Report Source: HEALTH PROFESSIONAL,USER FACI
• Date Received: 2020-03-09
• Date of Report: 2020-03-09
• Date of Event: 1980-01-01
• Date Mfgr Received: 2020-02-17
• Device Manufacturer Date: 2019-10-25
• Date Added to Maude: 2020-03-09
• 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
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: PATRICIA TUCKER
• Manufacturer Street: 3651 BIRCHWOOD DR
• Manufacturer City: WAUKEGAN IL 60085
• Manufacturer Country: US
• Manufacturer Postal: 60085
• Manufacturer Phone: 8478874151
• Manufacturer G1: MEX03 MEXICO-JUAREZ PRESOURCE
• Manufacturer Street: C. ARCADIA 1580 , COL. TERRAZA
• Manufacturer City: CD.JUAREZ , CHIHUAHUA CP 32599
• Manufacturer Country: MX
• Manufacturer Postal Code: CP 32599
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: CARDIAC CATH TRAY (CTSRF)602
• Generic Name: CARDIAC CATHETERIZATION KIT
• Product Code: OES
• Date Received: 2020-03-09
• Model Number: SCVOCCTSRG
• Catalog Number: SCVOCCTSRG
• Lot Number: 336001
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Eval'ed by Mfgr: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: MEX03 MEXICO-JUAREZ PRESOURCE
• Manufacturer Address: C. ARCADIA 1580 , COL. TERRAZA CD.JUAREZ , CHIHUAHUA CP 32599 MX CP 32599

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2020-03-09