MAUDE Adverse Event Report: WEBTEC A DIVISION OF SCARPA HEALTHCARE BREATHE RIGHT NASAL STRIPS

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Death (1802); Cancer (3262)

Event Type  Death  

Manufacturer Narrative

Mfr report# 2320643-2016-00013 is associated with argus case (b)(4), breathe right nasal strips.

Event Description

Cancer [cancer].Case description: this case was reported by a consumer via interactive digital media and described the occurrence of cancer in a male patient who received breathe right nasal strips nasal strip (batch number unk, expiry date unknown) for drug use for unknown indication.On an unknown date, the patient started breathe right nasal strips.On an unknown date, an unknown time after starting breathe right nasal strips, the patient experienced cancer (serious criteria death, gsk medically significant and other: gsk medically significant).On an unknown date, the outcome of the cancer was fatal.The reported cause of death was cancer.It was unknown if the reporter considered the cancer to be related to breathe right nasal strips.This report is made by gsk without prejudice and does not imply any admission or liability for the incident or its consequences.Additional details, adverse event information was reported by consumers daughter via (b)(6) on 27 november 2016.She reported that her father died from cancer while using breathe right nasal strips.

• Brand Name: BREATHE RIGHT NASAL STRIPS
• Type of Device: NASAL STRIPS
• Manufacturer (Section D): WEBTEC A DIVISION OF SCARPA HEALTHCARE; 5900 middle view way; knoxville TN 37909
• Manufacturer (Section G): GSK
• Manufacturer Contact: po box 13398; research triangle park, NC 27709 ; 8888255249
• MDR Report Key: 6138008
• MDR Text Key: 61227002
• Report Number: 2320643-2016-00013
• Device Sequence Number: 1
• Product Code: LWF
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial
• Report Date: 11/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Date Manufacturer Received: 11/27/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Other