VENOVO VENOUS STENT SYSTEM VENEL16060

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,s report with the FDA on 2019-07-24 for VENOVO VENOUS STENT SYSTEM VENEL16060 manufactured by Angiomed Gmbh & Co. Medizintechnik Kg.

MAUDE Entry Details

• Report Number: 9681442-2019-00136
• MDR Report Key: 8822733
• Report Source: FOREIGN,HEALTH PROFESSIONAL,S
• Date Received: 2019-07-24
• Date of Report: 2019-07-24
• Date of Event: 2019-06-26
• Date Mfgr Received: 2019-06-27
• Device Manufacturer Date: 2016-07-26
• Date Added to Maude: 2019-07-24
• 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: JUDITH LUDWIG
• Manufacturer Street: 1625 W 3RD ST.
• Manufacturer City: TEMPE AZ 85281
• Manufacturer Country: US
• Manufacturer Postal: 85281
• Manufacturer Phone: 4803032689
• Manufacturer G1: ANGIOMED GMBH & CO. MEDIZINTECHNIK KG
• Manufacturer Street: WACHHAUSSTRASSE 6
• Manufacturer City: KARLSRUHE 76227
• Manufacturer Country: GM
• Manufacturer Postal Code: 76227
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: VENOVO VENOUS STENT SYSTEM
• Generic Name: VENOUS STENT SYSTEM
• Product Code: QAN
• Date Received: 2019-07-24
• Catalog Number: VENEL16060
• Lot Number: ANAU1739
• Device Expiration Date: 2018-07-13
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Eval'ed by Mfgr: R
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: ANGIOMED GMBH & CO. MEDIZINTECHNIK KG
• Manufacturer Address: WACHHAUSSTRASSE 6 KARLSRUHE 76227 GM 76227

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Hospitalization; 2. Required No Informationntervention	2019-07-24