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 Problem Complaint, Ill-Defined (2331)

Event Type  Injury  

Manufacturer Narrative

This report is associated with argus case (b)(4), breathe right nasal strips.

Event Description

Addicted to breathe right nasal strips.Case description: this case was reported by a consumer and described the occurrence of addiction in a male patient who received breathe right nasal strips nasal strip (batch number unk, expiry date unknown) for product used 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 addiction (serious criteria gsk medically significant and other: gsk medically significant ).Breathe right nasal strips was continued with no change.On an unknown date, the outcome of the addiction was unknown.The reporter considered the addiction to be related to breathe right nasal strips.Additional details, adverse event information was received on 19 december 2016.Consumer indicated that he was addicted to breathe right nasal strips (variant not specified).

• 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: 6210518
• MDR Text Key: 63427452
• Report Number: 2320643-2016-00014
• 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: 12/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Date Manufacturer Received: 12/19/2016
• 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): Other