MAUDE Adverse Event Report: ACCLARENT RELIEVA SPIN SINUPLASTY SYSTEM; INSTRUMENT, ENT MANUAL SURGICAL

Catalog Number RS0616M

Device Problem Aborted Charge (2288)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 02/02/2013

Event Type  Injury  

Event Description

This is a test report being submitted from a new system for johnson & johnson acclarent and that there was no actual complaint or event involved with this report.

Manufacturer Narrative

This is a test report being submitted from a new system for johnson & johnson acclarent and that there was no actual complaint or event involved with this report.This is a test report being submitted from a new system for johnson & johnson acclarent and that there was no actual complaint or event involved with this report.

• Brand Name: RELIEVA SPIN SINUPLASTY SYSTEM
• Type of Device: INSTRUMENT, ENT MANUAL SURGICAL
• Manufacturer (Section D): ACCLARENT; 1525-b o brien dr; menlo park CA
• Manufacturer Contact: izabel nielson ; 1525-b o brien dr; menlo park, CA 94025 ; 6506877492
• MDR Report Key: 4745671
• MDR Text Key: 5824474
• Report Number: 3005172759-2015-00009
• Device Sequence Number: 1
• Product Code: LRC
• Combination Product (y/n): N
• PMA/PMN Number: K111875
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 05/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/12/2017
• Device Catalogue Number: RS0616M
• Device Lot Number: 141212A-CM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/18/2014
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Weight: 136