HANEL IT60002

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-08-17 for HANEL IT60002 manufactured by Mavig Gmbh.

Event Text Entries

[24402520] Per email from (b)(6): this morning we had a patient incident during a cath lab procedure. The lead shield attached to the same arm as or portegra2 fell & hit the patient. The patient had a red spot on the face & arm where she was hit. No injury was reported. See scanned page.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 9680506-2015-00001
• MDR Report Key: 5015758
• Date Received: 2015-08-17
• Date of Report: 2015-08-06
• Date of Event: 2015-07-15
• Date Facility Aware: 2015-07-15
• Date Reported to FDA: 2015-08-06
• Date Reported to Mfgr: 2015-08-06
• Device Manufacturer Date: 2002-01-01
• Date Added to Maude: 2015-08-19
• 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: BIOMEDICAL ENGINEER
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: ALEXIA LEPERO-STOIAN
• Manufacturer Street: STAHLGRUBERRING 5
• Manufacturer City: MUNICH, BAVARIA 81829
• Manufacturer Postal: 81829
• Manufacturer Phone: 498942096
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Details

• Brand Name: HANEL
• Generic Name: TYPE 77/80 S
• Product Code: KPY
• Date Received: 2015-08-17
• Model Number: IT60002
• Device Expiration Date: 2009-12-01
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: 14 YR
• Device Eval'ed by Mfgr: R
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: MAVIG GMBH
• Manufacturer Address: STAHLGRUBERRING 5 MUNICH, BAVARIA 81829 81829

Patients

Patient Number	Treatment	Outcome	Date
1	0		2015-08-17