RAPID RHINO 750 EPISTAXIS DEVICE RR 750

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 2013-03-05 for RAPID RHINO 750 EPISTAXIS DEVICE RR 750 manufactured by Arthrocare Corporation.

Event Text Entries

[3192078] It was reported that the patient had to return to the hospital two additional times post operatively, because the rapid rhino balloon used for epistaxis deflated both times.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 3006524618-2013-00092
• MDR Report Key: 2997495
• Report Source: 06
• Date Received: 2013-03-05
• Date of Report: 2013-02-04
• Date of Event: 2013-02-04
• Date Mfgr Received: 2013-02-04
• Date Added to Maude: 2013-05-10
• 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: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 0
• Event Location: 0
• Manufacturer Contact: WENDY LAIRD
• Manufacturer Street: 7000 W WILLIAM CANNON DR, BLDG 1
• Manufacturer City: AUSTIN TX 78735
• Manufacturer Country: US
• Manufacturer Postal: 78735
• Manufacturer Phone: 5123585933
• Manufacturer G1: ARTHROCARE COSTA RICA
• Manufacturer City: LA AURORA, HEREDIA
• Manufacturer Country: CS
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: RAPID RHINO 750 EPISTAXIS DEVICE
• Generic Name: BALLOON, EPISTAXIS
• Product Code: EMX
• Date Received: 2013-03-05
• Catalog Number: RR 750
• Lot Number: FW03320-B
• Device Expiration Date: 2014-01-01
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: DA
• Device Eval'ed by Mfgr: R
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: ARTHROCARE CORPORATION
• Manufacturer Address: AUSTIN TX US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2013-03-05