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

Lot Number 51788DXXF17

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

Patient Problems Respiratory Distress (2045); Swelling (2091); Choking (2464)

Event Type  Injury  

Manufacturer Narrative

Mdr 2320643-2018-00002 is associated with (b)(4), breathe right nasal strips extra.

Event Description

Husband having choking [choking], husband having coughing [cough], husband having gaggng [gagging], husband having sleeplessness [sleeplessness], husband having swelling of face [facial swelling], husband having swelling of mouth [swollen mouth], husband having swelling of tongue [swollen tongue], husband having trouble breathing [difficulty breathing].Case description: this case was reported by a consumer and described the occurrence of choking in a (b)(6) male patient who received breathe right nasal strips (breathe right nasal strips extra) nasal strip (batch number 51788dxxf17, expiry date unknown) for snoring.On an unknown date, the patient started breathe right nasal strips extra at an unknown dose and frequency.On an unknown date, an unknown time after starting breathe right nasal strips extra, the patient experienced choking (serious criteria gsk medically significant), cough, gagging, sleeplessness, facial swelling, swollen mouth, swollen tongue and difficulty breathing.Breathe right nasal strips extra was discontinued (dechallenge was negative).On an unknown date, the outcome of the choking, cough, gagging, sleeplessness, facial swelling, swollen mouth, swollen tongue and difficulty breathing were not recovered/not resolved.It was unknown if the reporter considered the choking, cough, gagging, sleeplessness, facial swelling, swollen mouth, swollen tongue and difficulty breathing to be related to breathe right nasal strips extra.Additional details, adverse event information was received on 18 april 2018.The consumer called in about breathe right and asked if there was a side effect of swelling of face tongue and mouth.The consumer stated that her husband having trouble breathing, coughing, choking, gaging, sleeplessness, swelling of face, tongue and mouth.

• Brand Name: BREATHE RIGHT NASAL STRIPS EXTRA
• Type of Device: NASAL STRIPS
• Manufacturer (Section D): WEBTEC DIV OF SCARPA HEALTHCARE; knoxville TN
• Manufacturer Contact: po box 13398; research triangle park,,
• MDR Report Key: 7456896
• MDR Text Key: 106383928
• Report Number: 2320643-2018-00002
• 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
• Type of Report: Initial
• Report Date: 04/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Lot Number: 51788DXXF17
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/18/2018
• 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: 85 YR