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

Lot Number 4484P8084760

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Bruise/Contusion (1754); Hemorrhage/Bleeding (1888)

Event Date 04/05/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

Made him bleed [hemorrhage].Ripped skin off of nose [skin peeling].Case description: this case was reported by a consumer via call center representative and described the occurrence of bleeding in a (b)(6)-year-old male patient who received breathe right nasal strips (breathe right nasal strips tan) nasal strip (batch number 4484p8084760, expiry date april 2020) for product used for unknown indication.Concurrent medical conditions included blood pressure high, alcohol use (one beer a day) and caffeine consumer (2 cups of tea a day).Concomitant products included amlodipine.On an unknown date, the patient started breathe right nasal strips tan.On (b)(6) 2016, an unknown time after starting breathe right nasal strips tan, the patient experienced bleeding (serious criteria gsk medically significant) and skin peeling.On an unknown date, the outcome of the bleeding and skin peeling were unknown.The reporter considered the bleeding and skin peeling to be related to breathe right nasal strips tan.This report is made by gsk without prejudice and does not imply any admission or liability for the incident or its consequences.Additional details, the consumer called to advise that the breathe right nasal strips tan small/medium strips ripped the skin off of his nose and made him bleed.The consumer indicated that his nose was clean and dry, the lining was removed, the strip was applied to the correct part of the nose and the ends were pressed down and rubbed gently to secure.The consumer was a first time user of the product and did not see an health care professional following the onset of the events.The action taken for the device breathe right nasal strips was unknown.

Event Description

Made him bleed [epistaxis].Ripped skin off of nose [skin peeling].Case description: this case was reported by a consumer via call center representative and described the occurrence of bleeding in a (b)(6) year-old male patient who received breathe right nasal strips (breathe right nasal strips tan) nasal strip (batch number 4484p8084760, expiry date april 2020) for product used for unknown indication.Concurrent medical conditions included blood pressure high, alcohol use (one beer a day) and caffeine consumer (2 cups of tea a day).Concomitant products included amlodipine.On an unknown date, the patient started breathe right nasal strips tan.On (b)(6) 2016, an unknown time after starting breathe right nasal strips tan, the patient experienced bleeding (serious criteria gsk medically significant) and skin peeling.On an unknown date, the outcome of the bleeding and skin peeling were unknown.The reporter considered the bleeding and skin peeling to be related to breathe right nasal strips tan.This report is made by gsk without prejudice and does not imply any admission or liability for the incident or its consequences.Additional details, the consumer called to advise that the breathe right nasal strips tan small/medium strips ripped the skin off of his nose and made him bleed.The consumer indicated that his nose was clean and dry, the lining was removed, the strip was applied to the correct part of the nose and the ends were pressed down and rubbed gently to secure.The consumer was a first time user of the product and did not see an health care professional following the onset of the events.The action taken for the device breathe right nasal strips was unknown.This report is being resubmitted to capture corrections.The information was received on 19 april 2016 and is as follows: the event coding for the event made him bleed (hemorrhage) was changed to bleeding on nose and case was downgraded to non-serious.Comment: downgrade report.

• Brand Name: BREATHE RIGHT NASAL STRIPS TAN
• 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: 5586783
• MDR Text Key: 43013444
• Report Number: 2320643-2016-00002
• 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,Followup
• Report Date: 04/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Lot Number: 4484P8084760
• Date Manufacturer Received: 04/12/2016
• 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
• Patient Age: 67 YR