RUSCH 580214

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 2001-09-07 for RUSCH 580214 manufactured by Rusch Manufacturing Uk Ltd, Rusch Lurgan.

Event Text Entries

[217678] The customer reports that the rectal balloon came off in the patient.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 2429473-2001-00161
• MDR Report Key: 351171
• Report Source: 06
• Date Received: 2001-09-07
• Date of Report: 2001-09-05
• Date Mfgr Received: 2001-08-31
• Date Added to Maude: 2001-09-14
• 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: DONNA MCLEOD, ADMINISTRATOR
• 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: RUSCH
• Generic Name: RECTAL BALLOON
• Product Code: FAP
• Date Received: 2001-09-07
• Model Number: NA
• Catalog Number: 580214
• Lot Number: UNK
• ID Number: NA
• Operator: LAY USER/PATIENT
• Device Availability: Y
• Device Eval'ed by Mfgr: Y
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 340458
• Manufacturer: RUSCH MANUFACTURING UK LTD, RUSCH LURGAN
• Manufacturer Address: PORTADOWN ROAD NORTHERN IRELAND UK BT66 8RD
• Baseline Brand Name: RECTAL BALLOON
• Baseline Model No: NA
• Baseline Catalog No: 580214
• Baseline ID: NA
• Baseline Shelf Life Contained: *
• Baseline Shelf Life [Months]: *
• Baseline PMA Flag: N
• Baseline 510K PMN: Y
• Premarket Notification: K962472
• Baseline Preamendment: N
• Baseline Transitional: N
• 510k Exempt: N

Patients

Patient Number	Treatment	Outcome	Date
1	0		2001-09-07