IRRIGATION TRAY 68895

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2001-02-15 for IRRIGATION TRAY 68895 manufactured by Rusch Inc..

Event Text Entries

[225648] Customer reports that when draining the irrigation tray the plunger leaks.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 2429473-2001-00019
• MDR Report Key: 316997
• Report Source: 08
• Date Received: 2001-02-15
• Date of Report: 2001-02-15
• Date Mfgr Received: 2001-01-25
• Date Added to Maude: 2001-02-26
• 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
• Manufacturer Street: 2450 MEADOWBROOK PKWY
• Manufacturer City: DULUTH GA 30136
• Manufacturer Country: US
• Manufacturer Postal: 30136
• 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: IRRIGATION TRAY
• Generic Name: UROLOGY
• Product Code: EYN
• Date Received: 2001-02-15
• Model Number: NA
• Catalog Number: 68895
• Lot Number: S0177
• ID Number: NA
• Device Availability: Y
• Device Eval'ed by Mfgr: Y
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 306534
• Manufacturer: RUSCH INC.
• Manufacturer Address: 2450 MEADOWBROOK PKWY. DULUTH GA 30096 US
• Baseline Brand Name: PISTON SYRINGE IRRIGATION TRAY
• Baseline Model No: NA
• Baseline Catalog No: 68895
• Baseline ID: NA
• Baseline Device Family: UROLOGY
• Baseline Shelf Life Contained: *
• Baseline Shelf Life [Months]: *
• Baseline PMA Flag: N
• Baseline 510K PMN: Y
• Premarket Notification: K900737
• Baseline Preamendment: N
• Baseline Transitional: N
• 510k Exempt: N

Patients

Patient Number	Treatment	Outcome	Date
1	0		2001-02-15