MAUDE Adverse Event Report: WEBTEC DIV OF SCARPA HEALTHCARE BREATHE RIGHT NASAL STRIPS EXTRA CLEAR

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

Patient Problem Choking (2464)

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

He started choking [choking].It turns out he had eaten 17 strips [accidental device ingestion by a child].Case description: this case was reported by a consumer and described the occurrence of choking in a child male patient who received breathe right nasal strips (breathe right nasal strips extra clear) 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 extra clear at an unknown dose and frequency.On an unknown date, an unknown time after starting breathe right nasal strips extra clear, the patient experienced choking (serious criteria gsk medically significant) and accidental device ingestion by a child (serious criteria gsk medically significant).On an unknown date, the outcome of the choking and accidental device ingestion by a child were unknown.The reporter considered the choking to be related to breathe right nasal strips extra clear.It was unknown if the reporter considered the accidental device ingestion by a child to be related to breathe right nasal strips extra clear.Additional details, adverse event information was received via power review on 23 april 2019.Consumer reported that "last week, i left out a box of these strips and somehow my child got a hold of them.He started choking, so we ran him to the hospital.It turns out he had eaten 17 strips and needed to get his stomach pumped.Besides, product does not work whatsoever.I snore just as much as before, and it tore off an entire layer of skin off of my nose.My doctor said that the scar it left will be permanent.I will definitely be suing for damages".This case was linked with case (b)(4).

• Brand Name: BREATHE RIGHT NASAL STRIPS EXTRA CLEAR
• Type of Device: NASAL STRIPS
• Manufacturer (Section D): WEBTEC DIV OF SCARPA HEALTHCARE; knoxville TN
• Manufacturer Contact: po box 13398; research triangle park; 8888255249
• MDR Report Key: 8590672
• MDR Text Key: 144407124
• Report Number: 2320643-2019-00003
• Device Sequence Number: 1
• Product Code: LWF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2019
• Is this an Adverse Event Report?: Yes
• Device Operator: Lay User/Patient
• Date Manufacturer Received: 04/23/2019
• 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