USA ELITE SYSTEM/USA SERIES 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 1999-11-23 for USA ELITE SYSTEM/USA SERIES DISPOSABLE ACTIVE CORD DAC manufactured by Circon Acmi.

Event Text Entries

[21381264] Pt rec'd burns on inner thigh.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1519132-1999-00089
• MDR Report Key: 253011
• Report Source: 06
• Date Received: 1999-11-23
• Date of Report: 1999-11-23
• Date Mfgr Received: 1999-11-05
• Date Added to Maude: 1999-12-10
• 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
• Reporter Occupation: RISK MANAGER
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 0
• Manufacturer Contact: RONALD EHMSEN, SC.D.
• Manufacturer Street: 6500 HOLLISTER AVE
• Manufacturer City: SANTA BARBARA CA 93117
• Manufacturer Country: US
• Manufacturer Postal: 93117
• Manufacturer Phone: 8059613290
• 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: USA ELITE SYSTEM/USA SERIES DISPOSABLE ACTIVE CORD
• Generic Name: ACTIVE CORD
• Product Code: FFZ
• Date Received: 1999-11-23
• Model Number: DAC
• Catalog Number: DAC
• Lot Number: EC 13S17
• ID Number: NA
• Operator: HEALTH PROFESSIONAL
• Device Availability: *
• Device Eval'ed by Mfgr: R
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 244988
• 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		1999-11-23