DISPOSABLE ACTIVE CORD DAC

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2002-03-11 for DISPOSABLE ACTIVE CORD DAC manufactured by Circon Acmi.

Event Text Entries

[271764] "product is defective. " drs gloves was burnt.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1519132-2002-00022
• MDR Report Key: 382497
• Report Source: 06
• Date Received: 2002-03-11
• Date of Report: 2002-03-11
• Date of Event: 2002-02-13
• Date Facility Aware: 2002-02-13
• Report Date: 2002-03-11
• Date Mfgr Received: 2002-03-06
• Date Added to Maude: 2002-03-20
• 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: FRANK FUCILE
• Manufacturer Street: 136 TURNPIKE RD.
• Manufacturer City: SOUTHBOROUGH MA 01772
• Manufacturer Country: US
• Manufacturer Postal: 01772
• Manufacturer Phone: 5088402632
• 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: DISPOSABLE ACTIVE CORD
• Generic Name: 500
• Product Code: FFZ
• Date Received: 2002-03-11
• Returned To Mfg: 2002-03-06
• Model Number: DAC
• Catalog Number: DAC
• Lot Number: KE5709
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: R
• Device Eval'ed by Mfgr: Y
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 371571
• Manufacturer: CIRCON ACMI
• Manufacturer Address: 93 NORTH PLEASANT ST NORWALK OH 448570409 US
• Baseline Brand Name: DISPOSABLE ACTIVE CORD
• Baseline Generic Name: ACTIVE CORD
• Baseline Model No: DAC
• Baseline Catalog No: DAC
• Baseline ID: NA
• Baseline Device Family: ACTIVE CORD
• Baseline Shelf Life [Months]: NA
• Baseline PMA Flag: N
• Baseline 510K PMN: N
• Baseline Preamendment: Y
• Baseline Transitional: N
• 510k Exempt: N

Patients

Patient Number	Treatment	Outcome	Date
1	0		2002-03-11