MAUDE Adverse Event Report: WEBTEC DIV OF SCARPA HEALTHCARE RINAZINA BREATHE RIGHT CLASSIC; NASAL STRIPS

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

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

Argus case: (b)(4).

Event Description

Classic patches have caused bleeding [hemorrhage].Skin irritation [skin irritation].Case description: this case was reported by a consumer via call center representative and described the occurrence of hemorrhage in a female patient who received breathe right nasal strips (rinazina breathe right classic) nasal strip (batch number unk, expiry date unknown) for product used for unknown indication.On an unknown date, the patient started rinazina breathe right classic.On an unknown date, an unknown time after starting rinazina breathe right classic, the patient experienced hemorrhage (serious criteria gsk medically significant) and skin irritation.The action taken with rinazina breathe right classic was unknown.On an unknown date, the outcome of the hemorrhage and skin irritation were unknown.It was unknown if the reporter considered the hemorrhage and skin irritation to be related to rinazina breathe right classic.This report is made by gsk without prejudice and does not imply any admission or liability for the incident or its consequences.Additional information: adverse event information was received via call center representative on 18 feb 2021.A consumer calls to ask about the availability of the clear rinazina patches and also adds that the classic patches have caused her skin irritation and bleeding.

• Brand Name: RINAZINA BREATHE RIGHT CLASSIC
• Type of Device: NASAL STRIPS
• Manufacturer (Section D): WEBTEC DIV OF SCARPA HEALTHCARE; knoxville TN
• Manufacturer Contact: po box 13398; research triangle park, NC ; 8888255249
• MDR Report Key: 11474999
• MDR Text Key: 239707039
• Report Number: 2320643-2021-00001
• 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,foreign
• Type of Report: Initial
• Report Date: 02/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/18/2021
• 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