OLIVE TIP FILIFORM 342104

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 1999-05-16 for OLIVE TIP FILIFORM 342104 manufactured by Rusch, Inc..

Event Text Entries

[16786854] It was reported that while being removed, the tip of the filiform became detached. Cystoscopy was performed and the tip was removed surgically.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 2429473-1999-00040
• MDR Report Key: 223699
• Report Source: 06
• Date Received: 1999-05-16
• Date of Report: 1999-05-13
• Date of Event: 1999-04-27
• Date Mfgr Received: 1999-05-12
• Date Added to Maude: 1999-05-20
• 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: 0
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: OLIVE TIP FILIFORM
• Generic Name: FILIFORM
• Product Code: FBW
• Date Received: 1999-05-16
• Model Number: NA
• Catalog Number: 342104
• Lot Number: E911607
• ID Number: NA
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Eval'ed by Mfgr: R
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 216941
• Manufacturer: RUSCH, INC.
• Manufacturer Address: 2450 MEADOWBROOK PKWY. DULUTH GA 30096 US
• Baseline Brand Name: OLIVE TIP FILIFORM
• Baseline Generic Name: FILIFORM
• Baseline Model No: NA
• Baseline Catalog No: 342104
• Baseline ID: NA
• Baseline Device Family: 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	1. Other	1999-05-16