MAUDE Adverse Event Report: ARTHROCARE CORPORATION STAMMBERGER SINUS DRESSING; NASAL DRESSING

Catalog Number RR 650

Device Problem Packaging Problem (3007)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/16/2014

Event Type  malfunction  

Event Description

It was reported that prior to a sinus procedure using the stammberger sinus dressing, it was discovered that the package allegedly had two labels on it, each with different lot numbers.The surgeon opted to procedure with a competitive device.There were no patient complications reported as a result of this device.

• Brand Name: STAMMBERGER SINUS DRESSING
• Type of Device: NASAL DRESSING
• Manufacturer (Section D): ARTHROCARE CORPORATION; austin TX
• Manufacturer (Section G): ARTHROCARE COSTA RICA; la aurora, heredia ; CS
• Manufacturer Contact: wendy laird ; 7000 w william cannon dr; bldg. 1; austin, TX 78735 ; 5123585933
• MDR Report Key: 4309554
• MDR Text Key: 15810170
• Report Number: 3006524618-2014-00341
• Device Sequence Number: 1
• Product Code: LYA
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 11/05/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2016
• Device Catalogue Number: RR 650
• Device Lot Number: 4000128
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/05/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/08/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other