URETHRAL FILIFORM 342704 AND/OR 342705

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 1999-11-17 for URETHRAL FILIFORM 342704 AND/OR 342705 manufactured by Rusch, Inc..

Event Text Entries

[16263401] It was reported that the material of the filiform cracked during use. It was reported that there was no harm to the pt.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 2429473-1999-00096
• MDR Report Key: 252084
• Report Source: 06
• Date Received: 1999-11-17
• Date of Report: 1999-11-15
• Date of Event: 1999-11-04
• Date Mfgr Received: 1999-11-04
• Date Added to Maude: 1999-12-03
• 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: KATRINA HALBIG, QUALITY ADMIN
• 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: URETHRAL FILIFORM
• Generic Name: FILIFORM
• Product Code: FBW
• Date Received: 1999-11-17
• Model Number: NA
• Catalog Number: 342704 AND/OR 342705
• Lot Number: 98301
• ID Number: NA
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Eval'ed by Mfgr: N
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 244140
• Manufacturer: RUSCH, INC.
• Manufacturer Address: 2450 MEADOWBROOK PKWY. DULUTH GA 30096 US
• Baseline Brand Name: URETHRAL FILIFORM
• Baseline Generic Name: FILIFORM
• Baseline Model No: NA
• Baseline Catalog No: 342704 AND/OR 342705
• Baseline ID: NA

Patients

Patient Number	Treatment	Outcome	Date
1	0		1999-11-17