ROTATING C/F VISUAL OBTURATOR ERVO-CF25

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2002-06-06 for ROTATING C/F VISUAL OBTURATOR ERVO-CF25 manufactured by Acmi Norwalk.

Event Text Entries

[270581] Customer wants product check to make sure product is within specs. Patient ablation burn, no permanent injury to patient.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1519132-2002-00045
• MDR Report Key: 398794
• Report Source: 05,06
• Date Received: 2002-06-06
• Date of Report: 2002-06-03
• Date of Event: 2002-05-07
• Date Facility Aware: 2002-05-08
• Date Mfgr Received: 2002-05-07
• Device Manufacturer Date: 1996-01-01
• Date Added to Maude: 2002-06-12
• 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: 0
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: DON KEREN
• Manufacturer Street: 136 TURNPIKE RD
• Manufacturer City: SOUTHBOROUGH MA 01772
• Manufacturer Country: US
• Manufacturer Postal: 01772
• Manufacturer Phone: 5088042708
• Manufacturer G1: *
• Manufacturer Street: *
• Manufacturer City: *
• Manufacturer Country: *
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: ROTATING C/F VISUAL OBTURATOR
• Generic Name: FEC
• Product Code: FEC
• Date Received: 2002-06-06
• Model Number: ERVO-CF25
• Catalog Number: ERVO-CF25
• Lot Number: *
• ID Number: *
• Device Availability: Y
• Device Age: 6 YR
• Device Eval'ed by Mfgr: Y
• Implant Flag: N
• Date Removed: U
• Device Sequence No: 1
• Device Event Key: 387838
• Manufacturer: ACMI NORWALK
• Manufacturer Address: 93 NORTH PLEASANT STREET NORWALK OH 448570409 US
• Baseline Brand Name: ROTATING C/F VISUAL OBTURATOR
• Baseline Generic Name: FEC
• Baseline Model No: ERVO-CF25
• Baseline Catalog No: ERVO-CF25
• Baseline ID: *

Patients

Patient Number	Treatment	Outcome	Date
1	0		2002-06-06