FILIFORM 342704

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2003-06-18 for FILIFORM 342704 manufactured by Rusch Inc..

Event Text Entries

[274636] Customer reports device cracked at metal part.
Patient Sequence No: 1, Text Type: D, B5

[18333482] Customer reports device cracked at metal part.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 2429473-2003-00064
• MDR Report Key: 467353
• Report Source: 05
• Date Received: 2003-06-18
• Date of Report: 2003-06-05
• Date Mfgr Received: 2003-06-05
• Date Added to Maude: 2003-06-25
• 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: 0
• Manufacturer Contact: ROLANDA SCOTT COORDINATOR
• Manufacturer Street: 2450 MEADOWBROOK PARKWAY
• Manufacturer City: DULUTH GA 30096
• Manufacturer Country: US
• Manufacturer Postal: 30096
• Manufacturer Phone: 7706230816
• 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: FILIFORM
• Generic Name: UROLOGICAL
• Product Code: FAX
• Date Received: 2003-06-18
• Model Number: NA
• Catalog Number: 342704
• Lot Number: 93535
• ID Number: NA
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Eval'ed by Mfgr: Y
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 456298
• Manufacturer: RUSCH INC.
• Manufacturer Address: 2450 MEADOWBROOK PARKWAY DULUTH GA 30096 US
• Baseline Brand Name: FILIFORM WITH SPIRAL TIP
• Baseline Generic Name: URETERAL FILIFORM
• Baseline Model No: NA
• Baseline Catalog No: 342704
• Baseline ID: NA
• Baseline Device Family: URETERAL FILIFORM
• Baseline Shelf Life Contained: *
• Baseline Shelf Life [Months]: *
• 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		2003-06-18